Label Name Reason 12-PANEL POC KIT TOXICOLO Diagnostic Agent 1ST BASE CRE Bulk Ingredient 1ST MEDX-PTC PAD LIDOCAIN Unapproved Drug 3ML GLAS SYR KIT NA HEPAR Diagnostic Agent 5ML GLAS SYR KIT NA HEPAR Diagnostic Agent 7T GUMMY ES CHW 500MG Unapproved Drug A.A.G.C KIT CRE TERODERM Not properly listed with FDA ABANEU-SL SUB Vitamin/Mineral ACACIA EXTRA SOL 1:20 Non-standardized allergenic ACCUCAINE INJ 1% LIST ACD FORMULA SOL A Blood Component ACESO AG PAD 4"X4" Surgical Supply/Medical ACREMONIUM SOL 20000PNU Non-standardized allergenic ACTCT FLEX 3 PAD 4"X4" Not properly listed with FDA ACTHREL INJ 100MCG Diagnostic Agent ACTI ANTIMIC PAD 2"X2" Not properly listed with FDA ACTI ANTIMIC PAD 4"X4" Not properly listed with FDA ACTICOAT 7 PAD 2"X2" Not properly listed with FDA ACTICOAT 7 PAD 4"X5" Not properly listed with FDA ACTICOAT ABS PAD 4"X5" Not properly listed with FDA ACTICOAT MOI PAD 2"X2" Surgical Supply/Medical ACTICOAT MOI PAD 4"X4" Surgical Supply/Medical ACTICOAT MOI PAD 4"X8" Surgical Supply/Medical ACTICOAT SUR PAD 4"X10" Surgical Supply/Medical ACTICOAT SUR PAD 4"X8" Surgical Supply/Medical ACTICOAT SUR PAD 4X13.75" Surgical Supply/Medical ACTICOAT SUR PAD 4X4-3/4" Surgical Supply/Medical ACTIVASE INJ 50MG LIST ACTIVE KIT INJECT L Bulk Ingredient ACTIVE INJEC INJ DL Bulk Ingredient ACTIVE INJEC INJ M-1 Bulk Ingredient ACTIVE INJEC KIT BLM-1 Bulk Ingredient ACTIVE INJEC KIT BM Bulk Ingredient ACTIVE INJEC KIT D Bulk Ingredient ACTIVE INJEC KIT DLM Bulk Ingredient ACTIVE INJEC KIT KET-L Bulk Ingredient ACTIVE INJEC KIT KETMARC Bulk Ingredient ACTIVE INJEC KIT KL-3 Bulk Ingredient ACTIVE INJEC KIT KM Bulk Ingredient ACTIVE INJEC KIT LM-2 Bulk Ingredient ACTIVE INJEC KIT LM-DEP-1 Bulk Ingredient ACTIVE INJEC KIT LM-DEP-2 Not properly listed with FDA ACTIVE MEDIC KIT SPECIMEN Diagnostic Agent ACTIVE-PAC/ MIS GABA 300 LIST ACTIVE-PREP CRE KIT I Bulk Ingredient MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021 Reason: LIST = multiple reasons it's excluded; "not covered under Part D law" Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA. Reason: DESI = Less Than Effective (LTE) drug for ALL indications
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Label Name Reason12-PANEL POC KIT TOXICOLO Diagnostic Agent1ST BASE CRE Bulk Ingredient1ST MEDX-PTC PAD LIDOCAIN Unapproved Drug3ML GLAS SYR KIT NA HEPAR Diagnostic Agent5ML GLAS SYR KIT NA HEPAR Diagnostic Agent7T GUMMY ES CHW 500MG Unapproved DrugA.A.G.C KIT CRE TERODERM Not properly listed with FDAABANEU-SL SUB Vitamin/MineralACACIA EXTRA SOL 1:20 Non-standardized allergenicACCUCAINE INJ 1% LISTACD FORMULA SOL A Blood ComponentACESO AG PAD 4"X4" Surgical Supply/MedicalACREMONIUM SOL 20000PNU Non-standardized allergenicACTCT FLEX 3 PAD 4"X4" Not properly listed with FDAACTHREL INJ 100MCG Diagnostic AgentACTI ANTIMIC PAD 2"X2" Not properly listed with FDAACTI ANTIMIC PAD 4"X4" Not properly listed with FDAACTICOAT 7 PAD 2"X2" Not properly listed with FDAACTICOAT 7 PAD 4"X5" Not properly listed with FDAACTICOAT ABS PAD 4"X5" Not properly listed with FDAACTICOAT MOI PAD 2"X2" Surgical Supply/MedicalACTICOAT MOI PAD 4"X4" Surgical Supply/MedicalACTICOAT MOI PAD 4"X8" Surgical Supply/MedicalACTICOAT SUR PAD 4"X10" Surgical Supply/MedicalACTICOAT SUR PAD 4"X8" Surgical Supply/MedicalACTICOAT SUR PAD 4X13.75" Surgical Supply/MedicalACTICOAT SUR PAD 4X4-3/4" Surgical Supply/MedicalACTIVASE INJ 50MG LISTACTIVE KIT INJECT L Bulk IngredientACTIVE INJEC INJ DL Bulk IngredientACTIVE INJEC INJ M-1 Bulk IngredientACTIVE INJEC KIT BLM-1 Bulk IngredientACTIVE INJEC KIT BM Bulk IngredientACTIVE INJEC KIT D Bulk IngredientACTIVE INJEC KIT DLM Bulk IngredientACTIVE INJEC KIT KET-L Bulk IngredientACTIVE INJEC KIT KETMARC Bulk IngredientACTIVE INJEC KIT KL-3 Bulk IngredientACTIVE INJEC KIT KM Bulk IngredientACTIVE INJEC KIT LM-2 Bulk IngredientACTIVE INJEC KIT LM-DEP-1 Bulk IngredientACTIVE INJEC KIT LM-DEP-2 Not properly listed with FDAACTIVE MEDIC KIT SPECIMEN Diagnostic AgentACTIVE-PAC/ MIS GABA 300 LISTACTIVE-PREP CRE KIT I Bulk Ingredient
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ACTIVE-PREP CRE KIT II Bulk IngredientACTIVE-PREP CRE KIT III Bulk IngredientACTIVE-PREP CRE KIT IV Bulk IngredientACTIVE-PREP CRE KIT V Bulk IngredientACTIVITE TAB Vitamin/MineralACUICYN SOL Not properly listed with FDAACUNOL TAB 600MG Unapproved DrugADA SHA Not properly listed with FDAADAP/BEN/NIA GEL Unapproved DrugADAP/BENZ/ GEL CLINDAMY Unapproved DrugADAPTADERM CRE Not properly listed with FDAADC/FLUORIDE DRO 0.5MG Vitamin/MineralADDYI TAB 100MG Sexual Dysfunction AgentADENOSINE INJ 3MG/ML Diagnostic AgentADENOSINE INJ 6MG/2ML Diagnostic AgentADENOSINE INJ 90/30ML Diagnostic AgentADIPEX-P CAP 37.5MG Anorexic, Anti-obestiy AgentADIPEX-P TAB 37.5MG Anorexic, Anti-obestiy AgentADRENAL C TAB FORMULA Vitamin/MineralADREVIEW INJ Diagnostic AgentADV ALLERGY KIT COLLECTI Not properly listed with FDAADVANCED MIS AM/PM Vitamin/MineralADVANCED BAS CRE PLUS Not properly listed with FDAADVATE INJ 1000UNIT Blood ComponentADVATE INJ 1500UNIT Blood ComponentADVATE INJ 2000UNIT Blood ComponentADVATE INJ 250UNIT Blood ComponentADVATE INJ 3000UNIT Blood ComponentADVATE INJ 4000UNIT Blood ComponentADVATE INJ 500UNIT Blood ComponentADYNOVATE INJ 1000UNIT Blood ComponentADYNOVATE INJ 1500UNIT Blood ComponentADYNOVATE INJ 2000UNIT Blood ComponentADYNOVATE INJ 250UNIT Blood ComponentADYNOVATE INJ 3000UNIT Blood ComponentADYNOVATE INJ 500UNIT Blood ComponentADYNOVATE INJ 750UNIT Blood ComponentADYPHREN KIT LISTADYPHREN AMP KIT 1MG/ML Unapproved DrugADYPHREN II KIT Unapproved DrugAFLURIA INJ 2018-19 Influenza VaccineAFLURIA INJ PF 18-19 Influenza VaccineAFLURIA QUAD INJ 2018-19 Influenza VaccineAFLURIA QUAD INJ 2019-20 Influenza VaccineAFLURIA QUAD INJ 2020-21 Influenza Vaccine
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
AFLURIA QUAD INJ PF 18-19 Influenza VaccineAFSTYLA KIT 1000UNIT Blood ComponentAFSTYLA KIT 1500UNIT Blood ComponentAFSTYLA KIT 2000UNIT Blood ComponentAFSTYLA KIT 2500UNIT Blood ComponentAFSTYLA KIT 250UNIT Blood ComponentAFSTYLA KIT 3000UNIT Blood ComponentAFSTYLA KIT 500UNIT Blood ComponentAGONEAZE KIT 2.5-2.5% LISTAIF #2 DRUG CRE PREP KIT Not properly listed with FDAAIF #3 DRUG CRE PREP KIT Not properly listed with FDAAIRAVITE TAB Vitamin/MineralAK-FLUOR INJ 10% OP Diagnostic AgentAK-FLUOR INJ 25% OP Diagnostic AgentALA-QUIN CRE 3-0.5% DESIALBA-DERM CRE Unapproved DrugALBUKED 25 INJ 25% Blood ComponentALBUKED 5 INJ 5% Blood ComponentALBUMIN HUM INJ 25% Blood ComponentALBUMIN HUM INJ 5% Blood ComponentALBUMINAR-25 INJ 25% Blood ComponentALBUMINAR-5 INJ 5% Blood ComponentALBUMINEX SOL 25% Blood ComponentALBUMINEX SOL 5% Blood ComponentALBUMIN-ZLB INJ Blood ComponentALBUMIN-ZLB SOL 25% Blood ComponentALBURX INJ 5% Blood ComponentALBUTEIN INJ 25% Blood ComponentALBUTEIN INJ 5% Blood ComponentALCOHOL INJ 98% Unapproved DrugALCOHOL BASE GEL Not properly listed with FDAALCORTIN A GEL 1-2-1% DESIALDER EXTRAC SOL 1:20 Non-standardized allergenicALEVAMAX CRE Not properly listed with FDAALEVICYN GEL Not properly listed with FDAALEVICYN SOL DERMAL Not properly listed with FDAALEVICYN SG GEL ANTIPRUR Not properly listed with FDAALGESIS TAB Dietary SupplementALKERAN TAB 2MG Oral drug for cancer; infusion available under Part BALLEVYN AG MIS 6-3/4" Surgical Supply/MedicalALLEVYN AG MIS 9"X9"SAC Surgical Supply/MedicalALLEVYN AG PAD 2"X2" Surgical Supply/MedicalALLEVYN AG PAD 3"X3" Not properly listed with FDAALLEVYN AG PAD 4"X4" Surgical Supply/MedicalALLEVYN AG PAD 5"X5" Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ALLEVYN AG PAD 6"X6" Surgical Supply/MedicalALLEVYN AG PAD 7"X7" Not properly listed with FDAALLEVYN AG PAD 8"X8 Surgical Supply/MedicalALLEVYN GENT PAD 4"X4 Not properly listed with FDAALLEVYN GENT PAD 8"X8" Not properly listed with FDAALMOND INJ EXTRACT Diagnostic AgentALOQUIN GEL 1.25-1% DESIALPAWASH OIN Not properly listed with FDAALPHA-LIPOIC SOL ACID Unapproved DrugALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANATE INJ VWF/HUM Blood ComponentALPHANINE SD INJ 1000UNIT Blood ComponentALPHANINE SD INJ 1500UNIT Blood ComponentALPHANINE SD INJ 500UNIT Blood ComponentALPROLIX INJ 1000UNIT Blood ComponentALPROLIX INJ 2000UNIT Blood ComponentALPROLIX INJ 250UNIT Blood ComponentALPROLIX INJ 3000UNIT Blood ComponentALPROLIX INJ 4000UNIT Blood ComponentALPROLIX INJ 500UNIT Blood ComponentALPROSTADIL INJ 500MCG Erectile DysfunctionALTADERM CRE BASE Not properly listed with FDAALTAFLUOR SOL 0.25-0.4 Diagnostic AgentALTAFLUOR-BE SOL 0.25-0.4 Diagnostic AgentALTERNARIA SOL EXTRACT Non-standardized allergenicALZAIR NASAL SPR 800MG DeviceAMD FOAM PAD 4"X4" Not properly listed with FDAAMERICAN INJ SYCAMORE Non-standardized allergenicAMERICAN SOL BEECH Non-standardized allergenicAMERICAN SOL COCKROAC Non-standardized allergenicAMERICAN ELM SOL Non-standardized allergenicAMIDATE INJ 2MG/ML General AnestheticAMINO PM RMS CAP Not properly listed with FDAAMINOAC ACID SOL 1.5% IRR Not properly listed with FDAAMINOAM CAP RMS Not properly listed with FDAAMINOBEZ POT POW DESIAMINORELIEF CAP RMS Not properly listed with FDAAMITRIPTYLIN CRE Not properly listed with FDAAMITRIPTYLIN KIT 2% Bulk IngredientAMLODIPINE SUS 1MG/ML LISTAMMONIA N 13 INJ Diagnostic AgentAMORPH WOUND GEL DRESSING Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
AMVISC INJ 12MG/ML DeviceAMVISC PLUS INJ 16MG/ML DeviceAMYTAL SOD INJ 500MG Unapproved DrugAMYVID INJ Diagnostic AgentANA-LEX KIT Unapproved DrugANALPRAM HC CRE 2.5-1% Unapproved DrugANALPRAM-HC CRE 1-1% Unapproved DrugANALPRAM-HC LOT 2.5% Unapproved DrugANALPRM SNGL CRE HC 2.5-1 Unapproved DrugANASCORP INJ LISTANASPAZ TAB 0.125MG Unapproved DrugANASTIA LOT 2.75% Not properly listed with FDAANAVIP INJ AntiveninANECTINE INJ 200/10ML LISTANECTINE INJ 20MG/ML LISTANESTHESIA KIT S/I-40 General AnestheticANESTHESIA KIT S/I-40A General AnestheticANESTHESIA KIT S/I-40H General AnestheticANESTHESIA KIT S/I-60 General AnestheticANHYDROUS CRE BASE Not properly listed with FDAANHYDROUS OIN BASE Not properly listed with FDAANIMI-3 CAP Vitamin/MineralANIMI-3 CAP Vitamin/MineralANIMI-3 CAP VIT D Vitamin/MineralANODYNE LPT KIT 2.5-2.5% LISTANTICOAG CIT SOL DEX SOL Unapproved DrugANTICOAGULNT INJ SOD CITR Unapproved DrugANTIPRURITIC GEL Not properly listed with FDAANTIVENIN KIT LAT MACT LISTANTIVENIN NA INJ CORAL SN LISTANUCORT-HC SUP 25MG DESIANUSOL-HC SUP 25MG DESIAPLISOL INJ 5/0.1ML Diagnostic AgentAPOTHEDERM CRE Not properly listed with FDAAPOTHESAR CRE PLUS Not properly listed with FDAAPOTHESAR CRE TRANSDER Not properly listed with FDAAPOTHESAR 2 CRE Not properly listed with FDAAPOTHESIL CRE Not properly listed with FDAAPP SLIM RMS CAP Not properly listed with FDAAPPLE INJ EXTRACT Diagnostic AgentAPPTRIM CAP Anorexic, Anti-obestiy AgentAPPTRIM-D CAP Anorexic, Anti-obestiy AgentAPP-TRIM-D CAP Anorexic, Anti-obestiy AgentAPRIZIO PAK KIT LISTAPRIZIO PAK KIT II LIST
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
AP-ZEL TAB Vitamin/MineralAQUASOL A INJ 50000/ML Vitamin/MineralAQUORAL SPR Not properly listed with FDAARIDA GEL Surgical Supply/MedicalARIDOL KIT Diagnostic AgentARIZONA INJ CYPRESS Non-standardized allergenicARMOUR THYRO TAB 120MG Unapproved DrugARMOUR THYRO TAB 15MG Unapproved DrugARMOUR THYRO TAB 180MG Unapproved DrugARMOUR THYRO TAB 240MG Unapproved DrugARMOUR THYRO TAB 300MG Unapproved DrugARMOUR THYRO TAB 30MG Unapproved DrugARMOUR THYRO TAB 60MG Unapproved DrugARMOUR THYRO TAB 90MG Unapproved DrugARNICA TIN FLOWER Unapproved DrugARNICA LG LIQ Unapproved DrugARTICADENT INJ DENTAL LISTARTICADENT INJ DENTAL LISTARZOL SILVER MIS NITR APP Unapproved DrugASCLERA INJ 0.5% LISTASCLERA INJ 1% LISTASCOR SOL 25000MG Vitamin/MineralASCORBIC ACD INJ 500MG/ML Vitamin/MineralASCORBIC ACI SOL 500MG/ML Unapproved DrugASILNASAL CAP RMS Not properly listed with FDAASPERGILLUS INJ 1:10 Non-standardized allergenicASPERGILLUS INJ 1:20 Diagnostic AgentASPERGILLUS INJ SOLN 1:20 Non-standardized allergenicASTAMED MYO CAP Not properly listed with FDAASTERO GEL 4% Not properly listed with FDAASTRINGYN SOL 259MG/GM Not properly listed with FDAATABEX EC TAB 29-1MG Vitamin/MineralATABEX OB TAB 29-1MG Vitamin/MineralATENOLOL SUS 1GM/ML LISTATOPADERM CRE DeviceATOPAVO EMU Surgical Supply/MedicalATOPICLAIR CRE DeviceATORVA/COQ10 PAK 20-100MG Not properly listed with FDAATRACURIUM INJ 10MG/ML LISTATRACURIUM INJ 10MG/ML LISTATRACURIUM INJ 50MG/5ML LISTATRAPRO GEL HYDROGEL DeviceATRAPRO CP KIT Not properly listed with FDAATRAPRO DERM SPR Not properly listed with FDAATREVIS CRE Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ATROPINE SUL INJ 1.2/3ML Unapproved DrugATROPINE SUL OIN 1% OP Unapproved DrugAUREOBASIDIU INJ 1:10 Non-standardized allergenicAUREOBASIDIU INJ 1:20 Diagnostic AgentAUREOBASIDIU SOL 1:20 Non-standardized allergenicAUSTRALIAN SOL PINE EXT Non-standardized allergenicAUXIPRO CRE VANISHIN Not properly listed with FDAAVAGE CRE 0.1% CosmeticAVAILNEX CHW 750MG Not properly listed with FDAAVAR AER 9.5-5% Unapproved DrugAVAR PAD 9.5-5% Unapproved DrugAVAR CLEANSE EMU 10-5% Unapproved DrugAVAR LS AER 10-2% Unapproved DrugAVAR LS LIQ 10-2% Unapproved DrugAVAR LS PAD 10-2% Unapproved DrugAVAR-E EMOLL CRE 10-5% Unapproved DrugAVAR-E GREEN CRE 10-5% Unapproved DrugAVAR-E LS CRE 10-2% Unapproved DrugAVEIDAOXIA GEL Not properly listed with FDAAVENOVA SOL 0.01% Not properly listed with FDAAVIDOXY DK KIT Not properly listed with FDAAVO CREAM EMU Surgical Supply/MedicalAVOCADO INJ EXTRACT Diagnostic AgentAXIFOL CAP 1/3760U Not properly listed with FDAAXONA POW Medical FoodAXUMIN INJ Diagnostic AgentAZADROX GEL Surgical Supply/MedicalAZALGIA CAP Dietary SupplementAZELAIC ACID CRE NIACINAM Unapproved DrugAZENASE PAK MIS 137-50 Not properly listed with FDAAZESCHEW CHW 13-1MG Vitamin/MineralAZESCO TAB 13-1MG Vitamin/MineralAZUPHEN MB CAP 120MG Unapproved DrugB-12 COMP KIT 1000MCG Vitamin/MineralB12 COMPLNCE KIT INJ KIT Vitamin/MineralB6 FOLIC ACD CAP Vitamin/MineralBACLOFEN CRE Not properly listed with FDABACLOFEN CRE 1% Bulk IngredientBACLOFEN CRE 2% Bulk IngredientBACMIN TAB Vitamin/MineralBACTER WATER INJ BENZ ALC Unapproved DrugBACTER WATER INJ PARABENS Unapproved DrugBAHIA SOL EXTRACT Non-standardized allergenicBAL SALT SOL OP LISTBAL-CARE MIS DHA Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
BALD CYPRESS INJ 1:20 Non-standardized allergenicBALSAM PERU OIN CASTOR DeviceBANANA INJ EXTRACT Diagnostic AgentBARIUM POW SULFATE Diagnostic AgentBASADROX GEL Surgical Supply/MedicalBASE CRE LIPOSOME Bulk IngredientBASE W301 CRE Not properly listed with FDABAYBERRY WAX SOL MYR EXTR Non-standardized allergenicBCAA INJ (AMINO ACID INJ SOLN) Unapproved DrugBCAA INJ (AMINO ACID IV SOLN) Unapproved DrugB-COMPLEX INJ Vitamin/MineralB-COMPLEX INJ 100 Vitamin/MineralB-COMPLEX INJ HYDRXCB Vitamin/MineralBD POSIFLUSH INJ 0.9% Not properly listed with FDABEAU RX GEL Not properly listed with FDABEE VENOM INJ 1300MCG Non-standardized allergenicBEE VENOM INJ 550MCG Non-standardized allergenicBEEF EXTRACT INJ 1:10 Diagnostic AgentBELLA ALK/PB TAB 16.2MG Unapproved DrugBELLA/OPIUM SUP 16.2-30 Unapproved DrugBELLA/OPIUM SUP 16.2-60 Unapproved DrugBELVIQ TAB 10MG Anorexic, Anti-obestiy AgentBELVIQ XR TAB 20MG Anorexic, Anti-obestiy AgentBENEFIX INJ 1000UNIT Blood ComponentBENEFIX INJ 2000UNIT Blood ComponentBENEFIX INJ 250UNIT Blood ComponentBENEFIX INJ 3000UNIT Blood ComponentBENEFIX INJ 500UNIT Blood ComponentBENSAL HP OIN Unapproved DrugBENZ PER FOR LOT HC 7.5-1 Not properly listed with FDABENZ PER- HC LOT 5-0.5% Not properly listed with FDABENZ PEROXID GEL 6.5% Not properly listed with FDABENZ/CLIN/ GEL NIACIN Unapproved DrugBENZ/CLIN/NI GEL Unapproved DrugBENZ/CLIND/ GEL NIA/TRET Unapproved DrugBENZ/CLIND/ GEL NIA/TRET Unapproved DrugBENZ/CLINDA/ GEL NIA/TRET Unapproved DrugBENZ/LIDO/TE OIN 20-10-10 Unapproved DrugBENZAC AC LIQ 5% WASH Unapproved DrugBENZALKONIUM SOL 50% Unapproved DrugBENZALKONIUM SOL NF Not properly listed with FDABENZEFOAM AER 5.3% Unapproved DrugBENZEFOAM AER 9.8% Unapproved DrugBENZEPRO AER 5.2% Not properly listed with FDABENZEPRO AER 5.3% Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
BENZEPRO AER 9.7% Not properly listed with FDABENZEPRO LIQ 6.8% Not properly listed with FDABENZEPRO LIQ CREAMY Unapproved DrugBENZEPRO MIS 5.8% Not properly listed with FDABENZEPRO MIS 6% Unapproved DrugBENZEPRO SC AER 9.8% Unapproved DrugBENZODOX 30 MIS Unapproved DrugBENZODOX 60 MIS Unapproved DrugBENZOIN TIN NF Unapproved DrugBENZOIN CMPD TIN Unapproved DrugBENZONATATE CAP 100MG Cough/ColdBENZONATATE CAP 150MG Cough/ColdBENZONATATE CAP 200MG Cough/ColdBENZOYL PER AER 9.8% Unapproved DrugBENZOYL PERO GEL 8% Not properly listed with FDABENZOYL PERX LIQ 6.9% Not properly listed with FDABENZPHETAMIN TAB 50MG Anorexic, Anti-obestiy AgentBENZPHETMINE TAB 25MG Anorexic, Anti-obestiy AgentBERMUDA SOL GRASS Non-standardized allergenicBERMUDA GRAS SOL 10000BAU LISTBESER KIT 0.05% LISTBETA 1 KIT KIT 30MG/5ML LISTBETALIDO KIT LISTBETALOAN SUI INJ 3-3MG/ML LISTBETAMETH SOD INJ 12MG/2ML Unapproved DrugBETAMETH SOD INJ 6MG/ML Unapproved DrugBETAMETHASON SOL MINOXIDI Unapproved DrugBETTERMILK PAK GLYTACTI Not properly listed with FDABETTERMILK15 POW GLYTACTN Not properly listed with FDABEVACIZUMAB INJ 2.5/.1ML Not properly listed with FDABEVACIZUMAB INJ 2.75MG Unapproved DrugBEVACIZUMAB INJ 3.25/.13 Not properly listed with FDABEVACIZUMAB INJ 3.75/.15 Not properly listed with FDABEVACIZUMAB INJ 3.75MG Unapproved DrugBHI URI- TAB CONTROL Unapproved DrugBIAFINE EMU Surgical Supply/MedicalBI-EST 50:50 CRE Not properly listed with FDABI-EST 50:50 MICRO CRE Not properly listed with FDABIEST/PROGES CRE Bulk IngredientBIIFENAC MIS 1000 KIT LISTBIIFENAC 500 MIS KIT LISTBIMATOPROST SOL 0.03% CosmeticBI-MIX INJ 150-5MG Erectile DysfunctionBINAXNOW KIT COVID-19 Diagnostic AgentBIO GLO TES 1MG OP Diagnostic Agent
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
BIOCEL TAB Vitamin/MineralBIOGRD ISLND PAD 4"X10" Not properly listed with FDABIOGRD ISLND PAD 4"X14" Not properly listed with FDABIOGRD ISLND PAD 4"X5" Not properly listed with FDABIOLON INJ 10MG/ML Not properly listed with FDABIONECT AER 0.2% Surgical Supply/MedicalBIONECT CRE 0.2% Surgical Supply/MedicalBIONECT GEL 0.2% Surgical Supply/MedicalBIOPEPTIDE CRE BASE Not properly listed with FDABIO-STATIN POW Not properly listed with FDABLACK WALNUT SOL POLL EXT Non-standardized allergenicBLACK WILLOW INJ 1:20 Non-standardized allergenicBLANCHE CRE 4% CosmeticBOCASAL POW Not properly listed with FDABONE MARROW KIT BIOPSY Not properly listed with FDABORIC ACID GRA Bulk IngredientBOTOX COSMET INJ 100UNIT CosmeticBOTOX COSMET INJ 50UNIT CosmeticBOTRYTIS CIN INJ 1:20 Diagnostic AgentBOTRYTIS EXT SOL 20000PNU Non-standardized allergenicBOTRYTIS EXT SOL 43000PNU Non-standardized allergenicBOX ELDER INJ EXT 1:20 Non-standardized allergenicBP 10-1 EMU Unapproved DrugBP CLEANSING EMU 10-4% Unapproved DrugBP FOAM AER 5.3% Unapproved DrugBP FOAM AER 9.8% Unapproved DrugBP VIT 3 CAP Vitamin/MineralBP WASH LIQ 2.5% Unapproved DrugBP WASH LIQ 7% Unapproved DrugBPCO OIN Not properly listed with FDAB-PLEX TAB Vitamin/MineralB-PLEX PLUS TAB Vitamin/MineralBPM TAB 6MG Unapproved DrugBPM PSEUDO TAB 6-45MG Unapproved DrugBPM-PSE-DM SYP 2-30-10 LISTBPO GEL 4% Unapproved DrugBPO GEL 8% Unapproved DrugBRAVELLE INJ 75UNIT Fertility AgentBRAVURA CRE ALL-IN-O Not properly listed with FDABREVITAL SOD INJ 2.5GM General AnestheticBREVITAL SOD INJ 500MG General AnestheticBROM/PSE/DM SYP Cough/ColdBROM/PSE/DM SYP 2/30/10 LISTBROM/PSE/DM SYP 2/30/10 LISTBROME SOL 1:20 Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
BROMFED DM SYP Cough/ColdBSP 0820 KIT LISTBSS SOL OP LISTBSS PLUS SOL OP LISTBT INJECTION KIT 40-0.5% Unapproved DrugBUPIV/NACL INJ 0.0625% Not properly listed with FDABUPIVAC HCL INJ 0.125% Unapproved DrugBUPIVAC/NACL INJ Not properly listed with FDABUPIVAC/NACL INJ 0.25-0.9 Not properly listed with FDABUPIVAC/NACL SOL 0.25-0.9 Not properly listed with FDABUPIVACA/D5W INJ /SPINAL LISTBUPIVACAINE INJ 312.5/10 Unapproved DrugBUPIVACAINE INJ SPINAL LISTBUPIVACAINE/ INJ EPI 0.25 LISTBUPIVACAINE/ INJ EPI 0.25 LISTBUPIVACAINE/ INJ EPI 0.5% LISTBUPIVACAINE/ INJ EPI 0.5% LISTBUPIVILOG KIT LISTCA ALGINATE MIS 12" ROPE Unapproved DrugCA ALGINATE PAD 2"X2" Unapproved DrugCA ALGINATE PAD 4"X4" Unapproved DrugCA ALGINATE PAD 4"X8" Unapproved DrugCADIRAMD KIT Unapproved DrugCAFFEINE/SOD INJ BENZOATE Unapproved DrugCALCIFOL WAF Vitamin/MineralCALCIPOTRIEN SOL CLOBETAS Unapproved DrugCALCIUM-FA WAF PLUS D Vitamin/MineralCALI PEPPER INJ TREE Non-standardized allergenicCALM INJ Unapproved DrugCAM PRO COMP BAR GLYTACTI Not properly listed with FDACAMINO PRO LIQ PKU Not properly listed with FDACANDIDA INJ ALBICANS Diagnostic AgentCANDIDA SOL ALBICANS Non-standardized allergenicCANDIDA ALBI INJ 1:20 Non-standardized allergenicCANDIDA ALBI SOL 100MG/ML Non-standardized allergenicCANDIN INJ Diagnostic AgentCANTALOUPE INJ EXTRACT Diagnostic AgentCAPECITABINE TAB 150MG Covered under Part B; oral drug only indicated for cancerCAPECITABINE TAB 500MG Covered under Part B; oral drug only indicated for cancerCAPHOSOL SOL DeviceCAPSFENAC PAK LISTCAPSINAC PAK LISTCAPSULE 0 CAP CLR DR Unapproved DrugCAPSULE CONI CAP -SN #000 Unapproved DrugCAPSULE CONI CAP -SNAP #0 Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
CAPSULE CONI CAP -SNAP #0 Unapproved DrugCAPSULE CONI CAP -SNAP #1 Unapproved DrugCAPSULE CONI CAP -SNAP #1 Unapproved DrugCAPSULE CONI CAP -SNAP #2 Unapproved DrugCAPSULE CONI CAP -SNAP #3 Unapproved DrugCAPSULE CONI CAP -SNAP #3 Unapproved DrugCAPSULE CONI CAP -SNAP #4 Unapproved DrugCAPSULE CONI CAP -SNAP#00 Unapproved DrugCAPSULE EZFT CAP #0 Not properly listed with FDACAPSULE EZFT CAP #00 Not properly listed with FDACARBOGEL GEL 940 Bulk IngredientCARBOHOL GEL 940 Bulk IngredientCARBOMER GEL AQUEOUS Bulk IngredientCARBOMER GEL HYDROALC Bulk IngredientCARDIOPL IND SOL 4:1 Not properly listed with FDACARDIOPL IND SOL 8:1 Not properly listed with FDACARDIOPL IND SOL LOW DEX8 Not properly listed with FDACARDIOPL IND SOL NON-EN 8 Not properly listed with FDACARDIOPL IND SOL PLASMA 4 Not properly listed with FDACARDIOPL IND SOL PLS/TROM Not properly listed with FDACARDIOPL MN SOL 8:1 Not properly listed with FDACARDIOPL MN SOL PLS/TROM Not properly listed with FDACARDIOPL REP SOL 4:1 Not properly listed with FDACARDIOPLE MN SOL LOW TROM Not properly listed with FDACARDIOPLEGI SOL DEL NIDO Not properly listed with FDACARDIOPLEGIA SOL MAIN 4:1 Not properly listed with FDACARDIOPLEGIC SOL LISTCARDIOTEK-RX TAB Vitamin/MineralCARDIOVID CAP PLUS Vitamin/MineralCARRASYN GEL DRESSING Not properly listed with FDACARTICEL IMP LISTCASCARA EXT SAGRADA Unapproved DrugCASEIN INJ EXTRACT Diagnostic AgentCAT HAIR SOL EXTRACT Non-standardized allergenicCAT HAIR EXT SOL 10000BAU LISTCAT HAIR EXT SOL 5000BAU LISTCATHFLO ACTI INJ 2MG LISTCATTLE EPITH SOL 1:20 Non-standardized allergenicCAVAREST GEL 1.1% Unapproved DrugCAVERJECT INJ 20MCG Erectile DysfunctionCAVERJECT INJ 40MCG Erectile DysfunctionCAVERJECT KIT 20MCG Erectile DysfunctionCAVERJECT IM KIT 10MCG Erectile DysfunctionCAYA DPR Not properly listed with FDACEDAR ELM INJ 1:20 Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
CEFTRI-IM KIT Not properly listed with FDACEFTRISOL KIT PLUS Not properly listed with FDACEFUROXIME INJ 3MG Unapproved DrugCELA BASE CRE Bulk IngredientCELACYN GEL Not properly listed with FDACEM-UREA SOL 45% Unapproved DrugCENFOL TAB Vitamin/MineralCENTANY AT KIT 2% LISTCERACADE EMU Not properly listed with FDACERAMAX CRE Not properly listed with FDACERAMAX LOT Not properly listed with FDACEREFOLIN TAB Vitamin/MineralCEREFOLIN TAB NAC Vitamin/MineralCEREFOLIN TAB NAC Vitamin/MineralCERETEC INJ Diagnostic AgentCERIANNA SOL 4-100 Diagnostic AgentCEROVEL LOT 40% Unapproved DrugCERVICAL MIS SPECIMEN Diagnostic AgentCETACAINE AER DESICETACAINE LIQ 2-2-14% Unapproved DrugCETROTIDE KIT 0.25MG Fertility AgentCHERRY SYP Bulk IngredientCHICKEN MEAT INJ EXTRACT Diagnostic AgentCHIRHOSTIM SOL 16MCG Diagnostic AgentCHLOOXIA CRE Not properly listed with FDACHLOOXIA OIN Not properly listed with FDACHLOOXIA SOL Not properly listed with FDACHLORHEX GLU SOL 20% Bulk IngredientCHOLECAL DF TAB Dietary SupplementCHOLETEC INJ Diagnostic AgentCHROMIUM CL INJ 4MCG/ML Not properly listed with FDACHRYSADERM CRE DAY Not properly listed with FDACHRYSADERM CRE NIGHT Not properly listed with FDACIALIS TAB 10MG Erectile DysfunctionCIALIS TAB 2.5MG* [Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only.] Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]CIALIS TAB 20MG Erectile DysfunctionCIALIS TAB 5MG* [Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only.] Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]CICLO/CLOBET SHA SAL ACID Unapproved DrugCICLODAN SOL KIT 8% LISTCICLOP/SALIC SHA 0.77-2% Unapproved DrugCICLOPIROX KIT 8% Unapproved DrugCICLOPIROX SHA CLOBETAS Unapproved DrugCIFEREX CAP Unapproved DrugCIFRAZOL CAP 1-3775 Unapproved DrugCIMETIDINE CRE LIDO/SAL Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
CISATRACURIU INJ 10MG/5ML LISTCISATRACURIU INJ 10MG/ML LISTCISATRACURIU INJ 20/10ML LISTCISATRACURIU INJ 200/20ML LISTCISATRACURIU INJ 2MG/ML Not properly listed with FDACITRANATAL CAP HARMONY Vitamin/MineralCITRANATAL CAP HARMONY Vitamin/MineralCITRANATAL CAP HARMONY Vitamin/MineralCITRANATAL CAP MEDLEY Vitamin/MineralCITRANATAL MIS Vitamin/MineralCITRANATAL MIS 90 DHA Vitamin/MineralCITRANATAL MIS B-CALM Vitamin/MineralCITRANATAL PAK ASSURE Vitamin/MineralCITRANATAL PAK DHA Vitamin/MineralCITRANATAL PAK ESSENCE Vitamin/MineralCITRANATAL TAB BLOOM Vitamin/MineralCITRANATAL TAB RX Vitamin/MineralCLADOSPORIUM INJ 1:20 Non-standardized allergenicCLADOSPORIUM INJ CLADOSPO Non-standardized allergenicCLADOSPORIUM SOL 1:20 Non-standardized allergenicCLADOSPORIUM SOL 20000PNU Non-standardized allergenicCLARISCAN INJ 10MMOL Diagnostic AgentCLARISCAN INJ 5MMOL Diagnostic AgentCLARISCAN INJ 7.5MMOL Diagnostic AgentCLIN SINGLE KIT USE LISTCLIN/NIACIN/ GEL SPRI/TRE Unapproved DrugCLIND/NIACIN CRE TRETINOI Unapproved DrugCLINDA/NIACI GEL 1-4% Unapproved DrugCLINDACIN KIT ETZ 1% LISTCLINDACIN KIT PAC 1% LISTCLINDAMYCIN LOT NIACIN Unapproved DrugCLINOIN CRE Not properly listed with FDACLINPRO 5000 PST 1.1% Unapproved DrugCLOBETASOL CRE NIACIN Unapproved DrugCLOBETASOL OIN NIACIN Unapproved DrugCLOBETASOL SHA LEVOCETI Unapproved DrugCLOBETASOL SOL NIACIN Unapproved DrugCLOBETAVIX KIT 0.05% LISTCLODAN KIT 0.05% LISTCLOMIPHENE TAB 50MG Fertility AgentCLOPIDOGREL MIS 75/81MG LISTC-NATE DHA CAP 28-1-200 Vitamin/MineralCOAGADEX INJ 250UNIT Blood ComponentCOAGADEX INJ 500UNIT Blood ComponentCOAL TAR SOL 20% Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
COCKLEBUR EX SOL 1:20 Non-standardized allergenicCOCOA BEAN INJ EXTRACT Diagnostic AgentCOD LIVER OIL Vitamin/MineralCODAR AR LIQ 2-8/5ML OTC ProductCOENZYME INJ Q-10 Unapproved DrugCOLCIGEL GEL Unapproved DrugCOLLATYL GEL DeviceCOLLODION LIQ FLEXIBLE Not properly listed with FDACOMPLETE NAT PAK DHA Vitamin/MineralCOMPLETENATE CHW Vitamin/MineralCO-NATAL FA TAB 29-1MG Vitamin/MineralCONCENTRATE CRE Not properly listed with FDACONCEPT DHA CAP Vitamin/MineralCONCEPT OB CAP Vitamin/MineralCONRAY INJ 60% Diagnostic AgentCONRAY 43 INJ 43% Diagnostic AgentCONTR ALLRGY KIT PREMD PK Unapproved DrugCONTRAVE TAB 8-90MG Anorexic, Anti-obestiy AgentCONVENIENCE PAK Not properly listed with FDACOPASIL GEL Not properly listed with FDACORIFACT KIT Blood ComponentCORN POLLEN SOL 1:20 Non-standardized allergenicCORTANE-B DRO AQ OTIC DESICORTANE-B DRO OTIC DESICORTANE-B LOT DESICORTIC-ND DRO DESICORTROSYN INJ 0.25MG Diagnostic AgentCORVITA TAB Vitamin/MineralCORVITE TAB Vitamin/MineralCORVITE FREE TAB Vitamin/MineralCOSYNTROPIN INJ 0.25MG Diagnostic AgentCOSYNTROPIN INJ 0.25MG Diagnostic AgentCOVARYX TAB 1.25-2.5 Unapproved DrugCOVARYX HS TAB DESICO-VERATROL CAP Unapproved DrugCRAB EXTRACT INJ 1:10 Diagnostic AgentCREAM BASE CRE Not properly listed with FDACREAM BASE CRE NIOSOMES Not properly listed with FDACREAM-HEAVY CRE BASE Not properly listed with FDACROFAB INJ Not properly listed with FDAC-TOPICAL SOL 4% Not properly listed with FDACURITY AMD MIS 1"X3' Not properly listed with FDACURITY AMD MIS 1/2"X3' Not properly listed with FDACURITY AMD MIS 1/4"X3' Not properly listed with FDACURITY AMD PAD 4"X4" Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
CURITY HYPER MIS 1/2"X15' Not properly listed with FDACURITY IODO MIS STRIP Not properly listed with FDACURITY NACL PAD 6"X6-3/4 Not properly listed with FDACURVULARIA INJ 20000PNU Non-standardized allergenicCUSHING SYND KIT DIAG Diagnostic AgentCUTIS PLUS CRE Bulk IngredientCYANOCOBALAM INJ 1000MCG Vitamin/MineralCYANOCOBALAM SOL 2000MCG Unapproved DrugCYCLO/GABA PAK 10/300 LISTCYCLOBENZAPR CRE 20MG/GM Bulk IngredientCYCLOBENZAPR CRE 5% KIT Bulk IngredientCYCLOPAK PAK Unapproved DrugCYCLOPHENE CRE RAPIDPAQ Unapproved DrugCYCLOSPORINE EMU 0.1% Unapproved DrugCYFOLEX CAP Vitamin/MineralCYSTO-CONRAY INJ II 17.2% Diagnostic AgentCYSTOGRAFIN INJ 30% Diagnostic AgentCYSTOGRAFIN- INJ DILUTE Diagnostic AgentCYSVIEW INJ 100MG Diagnostic AgentCYTRA K GRA CRYSTALS Unapproved DrugDANDELION INJ 1:20 LISTDAP/NIAC/SPI GEL 6-2-5% Unapproved DrugDAP/NIAC/SPI GEL 8.5-2-5% Unapproved DrugDAPS/NIACINA GEL 6-4% Unapproved DrugDAPSO/NIACIN GEL 8.5-4% Unapproved DrugDATSCAN SOL Diagnostic AgentDAVITE TAB Dietary Supplement D-CARE 100X KIT LISTD-CARE BLOOD TES GLUCOSE Diagnostic AgentDEBACTEROL SOL 30-50% DeviceDEFINITY SUS 1.1MG/ML Diagnostic AgentDELFLEX-LC SOL 1.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-LC/ SOL 2.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-LC/ SOL 4.25 DEX Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 1.5% DEX Dialysis covered by ESRD bundled paymentDELFLEX-SM/ SOL 2.5% DEX Dialysis covered by ESRD bundled paymentDELIVRA CRE SR Not properly listed with FDADELUO SPR LISTDENTA 5000 CRE PLUS Unapproved DrugDENTA 5000 CRE PLUS 2PK Unapproved DrugDENTAGEL GEL 1.1% Unapproved DrugDEOXIA GEL Not properly listed with FDADEOXIA LOT Not properly listed with FDADEPLIN 15 CAP Medical FoodDEPLIN 7.5 CAP Medical Food
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
DEPRIZINE SUS 22.4/ML Unapproved DrugDEPRIZINE SUS RAPIDPAQ Unapproved DrugDERMA SERUM CRE FREEDOM Not properly listed with FDADERMABASE CRE Not properly listed with FDADERMACINRX KIT 4-2-5% LISTDERMACINRX KIT ANALGESI LISTDERMACINRX KIT COMBOPAK LISTDERMACINRX KIT PHARMAPA LISTDERMACINRX KIT PRIZOPAK LISTDERMACINRX PAK Not properly listed with FDADERMACINRX PAK CINLONE LISTDERMACINRX PAK DUOPATCH Not properly listed with FDADERMACINRX PAK INFLAMMA LISTDERMACINRX PAK LEXITRAL Not properly listed with FDADERMACINRX PAK PHN LISTDERMACINRX PAK THERAZOL LISTDERMACINRX PAK ZRM LISTDERMACINRX SOL BASE LISTDERMASORB AF KIT 3-0.5% DESIDERMASORB HC KIT 2% Not properly listed with FDADERMASORB TA KIT 0.1% Not properly listed with FDADERMASORB XM KIT 39% Not properly listed with FDADERMAZENE CRE 1-1% Not properly listed with FDADERMAZYL PAK 5% LISTDERMULCERA OIN DeviceDESFLURANE SOL General AnestheticDETECTNET INJ 1MCL/ML Diagnostic AgentDEX/MOX/KETO SOL Unapproved DrugDEXAM/MOXI SOL 1-5MG/ML Unapproved DrugDEXAMETH-BUP INJ Not properly listed with FDADEXERYL CRE Not properly listed with FDADEXIFOL TAB Vitamin/MineralDEXLIDO KIT LISTDEXLIDO-M KIT LISTDEXONTO 0.4% SOL 20MG/5ML Unapproved DrugDEXOPIN KIT Unapproved DrugDFS DR/MS/ KIT MENT/CAP LISTDFS/MS/MENTH KIT /CAP PAK LISTDIAB GEL Not properly listed with FDADIAB F.D.G. GEL Not properly listed with FDADIABETIC CAP VITAMIN Unapproved DrugDIADIMAXIA GEL Not properly listed with FDADIALYVITE TAB Vitamin/MineralDIALYVITE TAB 3000 Vitamin/MineralDIALYVITE TAB 5000 Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
DIALYVITE TAB SUPREM D Vitamin/MineralDIALYVITE/ TAB ZINC Vitamin/MineralDIANEAL SOL LOW CALC Dialysis covered by ESRD bundled paymentDIANEAL SOL LOW CALC Dialysis covered by ESRD bundled paymentDIANEAL SOL LOW CALC Dialysis covered by ESRD bundled paymentDIANEAL PD-2 SOL 1.5% DEX Dialysis covered by ESRD bundled paymentDIANEAL PD-2 SOL 2.5% DEX Dialysis covered by ESRD bundled paymentDIANEAL PD-2 SOL 4.25%DEX Dialysis covered by ESRD bundled paymentDIAOXIA GEL Not properly listed with FDADIASDIMAXIA GEL Not properly listed with FDADIASOXIA GEL Not properly listed with FDADIC/HYAL/NIA GEL 3-2-4% Unapproved DrugDICLO GEL KIT 1% PAK LISTDICLO GEL PAK 1% LISTDICLOFEX DC MIS Not properly listed with FDADICLOFONO GEL 1.6% Unapproved DrugDICLOPAK PAK LISTDICLOPR KIT 1-10-30% LISTDICLOSAICIN MIS LISTDICLOSTREAM PAK 1.5-10% LISTDICLOTREX PAK LISTDICLOVIX KIT LISTDICLOVIX DM PAK 1.5-8% LISTDICLOZOR MIS 1% LISTDICOPANOL SUS 5MG/ML Unapproved DrugDICOPANOL SUS RAPIDPAQ Unapproved DrugDIETHYLPROP TAB 25MG Anorexic, Anti-obestiy AgentDIETHYLPROP TAB 75MG ER Anorexic, Anti-obestiy AgentDIFIL-G FORT LIQ 100-100 Unapproved DrugDIFMETIOXRIM SOL Not properly listed with FDADIMENTHO PAK LISTDIMOXIA GEL Not properly listed with FDADIPENTOCAINE CRE 5-5-2% Unapproved DrugDIPRIVAN INJ General AnestheticDIPRIVAN INJ 100/10ML General AnestheticDIPRIVAN INJ 200/20ML General AnestheticDIPRIVAN INJ 500/50ML General AnestheticDIPYRIDAMOLE INJ 5MG/ML Diagnostic AgentDITHOL MIS 1.5%-10% LISTDIVISTA CAP Vitamin/MineralDMSA KIT Diagnostic AgentDMT SUIK KIT 10MG/ML LISTDNA COLLECT KIT Diagnostic AgentDNA COLLECT KIT MEDICATE Diagnostic AgentDOG SOL EPITHELI Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
DOG EPITHELI SOL 1:20 Non-standardized allergenicDOG FENNEL SOL 1:20 Non-standardized allergenicDONNATAL ELX DESIDONNATAL ELX GRAPE Unapproved DrugDONNATAL ELX MINT Unapproved DrugDONNATAL TAB 16.2MG DESIDOTAREM INJ 10MMOL Diagnostic AgentDOTAREM INJ 2.5MMOL Diagnostic AgentDOTAREM INJ 50MMOL Diagnostic AgentDOTAREM INJ 5MMOL Diagnostic AgentDOTAREM INJ 7.5MMOL Diagnostic AgentDOTATOC INJ GA 68 Diagnostic AgentDOTHELLE DHA CAP Vitamin/MineralDOUBLE PM SOL Not properly listed with FDADOUBLEDEX KIT LISTDRAIN SPONGE PAD 4"X4" Not properly listed with FDADRAXACE SUS Not properly listed with FDADRAXACE LOT SUS CLEANSER Not properly listed with FDADRCAPS CLEAR CAP SIZE 0 Unapproved DrugDRCAPS CLEAR CAP SIZE 00 Unapproved DrugDRCAPS CLEAR CAP SIZE 1 Unapproved DrugDRECHSLERA SOL 1:10 Non-standardized allergenicDRECHSLERA SOL 1:20 Non-standardized allergenicDRIHEP PLUS KIT 100UNIT Diagnostic AgentDRIHEP SYRNG KIT 100UNIT Diagnostic AgentDRISDOL CAP 50000UNT Vitamin/MineralDRITHO-CREME CRE HP 1% Unapproved DrugDRIXECE SUS Not properly listed with FDADRYSOL SOL 20% Unapproved DrugDS PREP PAK PAK 1%-0.13% Unapproved DrugDST PLUS PAK KIT LISTDUAL COMPLEX CRE 1 KIT Not properly listed with FDADUET DHA MIS BALANCED Vitamin/MineralDUET DHA MIS BALANCED Vitamin/MineralDUET DHA MIS BALANCED Vitamin/MineralDUET DHA MIS BALANCED Vitamin/MineralDUET DHA 400 MIS 25-1-400 Vitamin/MineralDUET DHA 400 MIS 25-1-400 Vitamin/MineralDUODOTE INJ LISTDURABASE CRE Not properly listed with FDADURABASE CRE ADVANCED Not properly listed with FDADURACHOL CAP 1-3775IU Unapproved DrugDURAFIBER PAD 4X4-3/4" Surgical Supply/MedicalDURAFIBER AG PAD 2"X2" Surgical Supply/MedicalDURAFIBER AG PAD 3/4X18" Surgical Supply/Medical
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
DURAFIBER AG PAD 4"X4" Surgical Supply/MedicalDURAFIBER AG PAD 4X4-3/4" Surgical Supply/MedicalDURAFIBER AG PAD 6"X6" Surgical Supply/MedicalDURAFIBER AG PAD 8X11.75" Surgical Supply/MedicalDURAXIN CAP Unapproved DrugD-XYLOSE POW Diagnostic AgentDYNABAC 5.0 MIS LISTDYNAMIC KIT Diagnostic AgentDYNAMIC PLUS KIT PAK Diagnostic AgentDYURAL-40 KIT LISTDYURAL-80 KIT LISTDYURAL-L KIT LISTDYURAL-LM KIT LISTEASTERN SOL COTTONWO LISTEASYGEL GEL 0.4% Unapproved DrugEASYGEL GEL 0.4%CHRY Unapproved DrugEASYGEL GEL 0.4%CITR Unapproved DrugEASYGEL GEL 0.4%MINT Unapproved DrugECEOXIA CRE Not properly listed with FDAECONASIL KIT LISTECONAZOLE CRE NIACIN Unapproved DrugEC-RX DHEA CRE 10% Not properly listed with FDAEC-RX DHEA CRE 4% Not properly listed with FDAEC-RX ESTRAD CRE 0.4% Not properly listed with FDAEC-RX ESTRAD CRE 0.6% Not properly listed with FDAEC-RX PROGES CRE 10% Not properly listed with FDAEC-RX PROGES CRE 20% Not properly listed with FDAEC-RX TESTOS CRE 0.2% Not properly listed with FDAEC-RX TESTOS CRE 0.4% Not properly listed with FDAEC-RX TESTOS CRE 10% Not properly listed with FDAEC-RX TESTOS CRE 20% Not properly listed with FDAECZEMOL TAB Unapproved DrugEDETATE DISO INJ 150MG/ML Unapproved DrugEDEX KIT 10MCG Erectile DysfunctionEDEX KIT 20MCG Erectile DysfunctionEDEX KIT 40MCG Erectile DysfunctionED-SPAZ TAB 0.125MG Unapproved DrugEEMT TAB 1.25-2.5 DESIEEMT HS TAB DESIEFFER-K TAB 10MEQ Unapproved DrugEFFER-K TAB 20MEQ Unapproved DrugEFFER-K TAB 25MEQ EF Unapproved DrugEGG WHITE INJ EXTRACT Diagnostic AgentEHA LOT 4% Unapproved DrugELETONE CRE Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ELETONE CRE TWINPACK Not properly listed with FDAELFOLATE TAB 15MG Vitamin/MineralELFOLATE TAB 7.5MG Vitamin/MineralELFOLATE PLU TAB 3-35-2MG Vitamin/MineralELITE-OB TAB Vitamin/MineralELLZIA PAK PAK 0.1%/5% LISTELOCTATE INJ 1000UNIT Blood ComponentELOCTATE INJ 1500UNIT Blood ComponentELOCTATE INJ 2000UNIT Blood ComponentELOCTATE INJ 250UNIT Blood ComponentELOCTATE INJ 3000UNIT Blood ComponentELOCTATE INJ 4000UNIT Blood ComponentELOCTATE INJ 5000UNIT Blood ComponentELOCTATE INJ 500UNIT Blood ComponentELOCTATE INJ 6000UNIT Blood ComponentELOCTATE INJ 750UNIT Blood ComponentEMOLIVAN CRE Not properly listed with FDAEMOLLIENT CRE Not properly listed with FDAEMPRICAINE KIT 2.5-2.5% LISTEMPRICAINE KIT II LISTEMPTY CAPSUL CAP SIZE 0 Unapproved DrugEMPTY CAPSUL CAP SIZE 00 Unapproved DrugEMPTY CAPSUL CAP SIZE 1 Unapproved DrugEMPTY CAPSUL CAP SIZE 1 Unapproved DrugEMPTY CAPSUL CAP SIZE 2 Unapproved DrugEMPTY CAPSUL CAP SIZE 3 Unapproved DrugEMPTY CAPSUL CAP SIZE 4 Unapproved DrugEMPTY CAPSUL CAP SIZE 5 Unapproved DrugEMPTY CAPSUL CAP SIZE 7 Unapproved DrugEMULSION SB EMU Not properly listed with FDAENBRACE HR CAP Vitamin/MineralENDEAVORRX MIS LISTENDOMETRIN SUP 100MG Fertility AgentENGLISH SOL PLANTAIN Non-standardized allergenicENGYSTOL INJ Unapproved DrugENLYTE CAP Unapproved DrugENOVARX CRE 2.5% Not properly listed with FDAENTERAGAM POW 5GM Not properly listed with FDAENTERO VU SUS 24% Diagnostic AgentENTTY EMU SPRAY Not properly listed with FDAENU PRO3 POW PLUS Not properly listed with FDAENZADYNE CAP Not properly listed with FDAENZOCLEAR AER 9.8% Unapproved DrugEOVIST INJ Diagnostic AgentEPHEDRIN SUL INJ 25MG/5ML Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
EPHEDRINE INJ 25MG/5ML Not properly listed with FDAEPHEDRINE INJ 50/10ML Not properly listed with FDAEPHEDRINE INJ 50MG/5ML Not properly listed with FDAEPHEDRINE SU INJ 50MG/ML Unapproved DrugEPICERAM EMU LISTEPICOCC NIGR INJ 1:10 Non-standardized allergenicEPICOCCUM INJ 1:20 Non-standardized allergenicEPICOCCUM EX SOL 1:10 Non-standardized allergenicEPICYN SPR Not properly listed with FDAEPIFOAM AER 1% Unapproved DrugEPINEPHR PRO KIT 1MG/ML LISTEPINEPHRINE INJ 0.1MG/ML Unapproved DrugEPINEPHRINE INJ 1MG/10ML Unapproved DrugEPINEPHRINE KIT 1MG/ML LISTEPINPHEPHRIN KIT SNAP-V Not properly listed with FDAEPIQUIN MICR CRE 4% CosmeticEPISNAP KIT LISTEQUACARE JR POW CHOCO Dietary Supplement EQUACARE JR POW UNFLAVOR Dietary Supplement EQUACARE JR POW VANILLA Dietary Supplement ERECAID KIT CLASSIC Erectile DysfunctionERECAID KIT ESTEEM Erectile DysfunctionERGOCAL CAP 2500UNIT Vitamin/MineralESCAVITE CHW Vitamin/MineralESCAVITE D CHW Vitamin/MineralESCAVITE LQ DRO 0.25-6MG Vitamin/MineralESOMEP-EZS KIT 20MG LISTESPEROCT INJ 1000UNIT Blood ComponentESPEROCT INJ 1500UNIT Blood ComponentESPEROCT INJ 2000UNIT Blood ComponentESPEROCT INJ 3000UNIT Blood ComponentESPEROCT INJ 500UNIT Blood ComponentESPUMIL AER Bulk IngredientESSENTIAL POW CARE JR Dietary Supplement ESSENTRA MIS 9X9" Not properly listed with FDAEST ESTROGEN TAB MTEST HS DESIESTRIOL-PROG CRE Not properly listed with FDAESTROG/MTEST TAB 1.25-2.5 DESIETHOXIA CRE Unapproved DrugETHYL CHLOR AER FINE PIN Not properly listed with FDAETHYL CHLOR AER FN STRM Not properly listed with FDAETHYL CHLOR AER MED JET Not properly listed with FDAETHYL CHLOR AER MED STRM Not properly listed with FDAETHYL CHLOR AER MIST Not properly listed with FDAETHYL CHLOR AER SPRAY Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ETOMIDATE INJ 20/10ML General AnestheticETOMIDATE INJ 2MG/ML General AnestheticETOMIDATE INJ 40/20ML General AnestheticETOPOSIDE CAP 50MG Oral drug for cancer; infusion available under Part BEVICEL KIT 2ML Not properly listed with FDAEVICEL KIT 5ML Not properly listed with FDAEXODERM LOT 25-1% Unapproved DrugEXOTIC-HC DRO OTIC DESIEXTRANEAL SOL Dialysis covered by ESRD bundled paymentEXYDERM PAD Not properly listed with FDAEZ FLU SHOT INJ 2018-19 Influenza VaccineE-Z-CAT DRY PAK Diagnostic AgentE-Z-DISK TAB 700MG Diagnostic AgentE-Z-HD SUS 98% Diagnostic AgentE-Z-PAQUE SUS 60% Diagnostic AgentE-Z-PAQUE SUS 96% Diagnostic AgentE-Z-PASTE CRE 60% Diagnostic AgentFA-B6-B12 TAB Vitamin/MineralFABB TAB 2.2-25-1 Vitamin/MineralFAGRON LS CRE PLUS Not properly listed with FDAFALESSA KIT Unapproved DrugFANATREX SUS 25MG/ML Unapproved DrugFBL KIT CRE 15-4-5% Bulk IngredientFEIBA INJ Blood ComponentFEM PH GEL Not properly listed with FDAFEMCAP MIS 22MM DeviceFEMCAP MIS 26MM DeviceFEMCAP MIS 30MM DeviceFENTANYL INJ 50MCG/ML General AnestheticFENTANYL CIT INJ 0.05MG/1 General AnestheticFENTANYL CIT INJ 100/2ML General AnestheticFENTANYL CIT INJ 1000/20 General AnestheticFENTANYL CIT INJ 1000MCG General AnestheticFENTANYL CIT INJ 100MCG General AnestheticFENTANYL CIT INJ 1500/30 General AnestheticFENTANYL CIT INJ 1500MCG General AnestheticFENTANYL CIT INJ 250/5ML General AnestheticFENTANYL CIT INJ 2500/50 General AnestheticFENTANYL CIT INJ 2500MCG General AnestheticFENTANYL CIT INJ 250MCG General AnestheticFENTANYL CIT INJ 2750MCG General AnestheticFENTANYL CIT INJ 500MCG General AnestheticFENTANYL CIT INJ 50MCG/ML General AnestheticFENTANYL CIT SOL 2500/50 General AnestheticFENT-BUP-NAC INJ Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
FERAHEME INJ 510/17ML LISTFEROCON CAP Vitamin/MineralFEROTRINSIC CAP Vitamin/MineralFERRIC GLUCO INJ 12.5/ML Vitamin/MineralFERRIC GLUCO INJ 12.5MG/M Vitamin/MineralFERRLECIT INJ 12.5MG/M Vitamin/MineralFERRO-PLEX TAB Vitamin/MineralFERROTRIN CAP Vitamin/MineralFIBERSOUR HN LIQ Not properly listed with FDAFIBRIK CAP Vitamin/MineralFIBRYGA INJ 1GM Blood ComponentFIBRYGA INJ 1MG Blood ComponentFINASTERIDE SOL MINOXIDI Unapproved DrugFINASTERIDE TAB 1MG CosmeticFIRE ANT INJ 1:10 Non-standardized allergenicFIRE ANT EXT INJ 1:20 Non-standardized allergenicFIRST-ATENOL SOL 10MG/ML Not properly listed with FDAFIRST-ATENOL SOL 2MG/ML Not properly listed with FDAFIRST-BACLOF SUS 1 Not properly listed with FDAFIRST-BACLOF SUS 5 KIT Not properly listed with FDAFIRST-METO SOL 10MG/ML Not properly listed with FDAFIRST-METRON SUS 100MG/ML Not properly listed with FDAFIRST-METRON SUS 50MG/ML Not properly listed with FDAFIRST-MOUTHW SUS BLM Unapproved DrugFIRST-OMEPRA SUS 2MG/ML Bulk IngredientFIRST-VANC SOL 25MG/ML Not properly listed with FDAFIRST-VANC SOL 50MG/ML Not properly listed with FDAFITALITE CRE BASE Not properly listed with FDAFLAVOR BLEND SUS Unapproved DrugFLAVOR PLUS LIQ Unapproved DrugFLAVOR SWEET SYP Unapproved DrugFLAVOR SWEET SYP S/F Not properly listed with FDAFLEXBUMIN INJ 25% Blood ComponentFLEXBUMIN INJ 5% Blood ComponentFLEXIN PAD OTCFLEXIPAK PAK 75-0.025 LISTFLEXIZOL PAK COMBIPAK Not properly listed with FDAFLORIVA CHW 0.25MG Vitamin/MineralFLORIVA CHW 0.5MG Vitamin/MineralFLORIVA CHW 1MG Vitamin/MineralFLORIVA DRO 0.25MG Unapproved DrugFLORIVA DRO PLUS Vitamin/MineralFLUAD INJ 2018-19 Influenza VaccineFLUAD INJ 2019-20 Influenza VaccineFLUAD INJ 2020-21 Influenza Vaccine
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
FLUAD QUADRI INJ 0.5ML Influenza VaccineFLUARIX QUAD INJ 2018-19 Influenza VaccineFLUARIX QUAD INJ 2019-20 Influenza VaccineFLUARIX QUAD INJ 2020-21 Influenza VaccineFLUBLOK QUAD INJ 2018-19 Influenza VaccineFLUBLOK QUAD INJ 2019-20 Influenza VaccineFLUBLOK QUAD INJ 2020-21 Influenza VaccineFLUCAINE SOL 0.25-0.5 Diagnostic AgentFLUCLVX QUAD INJ 2018-19 Influenza VaccineFLUCLVX QUAD INJ 2019-20 Influenza VaccineFLUCLVX QUAD INJ 2020-21 Influenza VaccineFLUCON/IBU SOL ITRA/TER Unapproved DrugFLUDEOXYGLUC SOL 20-300 Diagnostic AgentFLULAVAL QUA INJ 2018-19 Influenza VaccineFLULAVAL QUA INJ 2019-20 Influenza VaccineFLULAVAL QUA INJ 2020-21 Influenza VaccineFLUMIST QUAD SUS 2018-19 Influenza VaccineFLUMIST QUAD SUS 2019-20 Influenza VaccineFLUMIST QUAD SUS 2020-21 Influenza VaccineFLUOCINOLONE CRE NIACIN Unapproved DrugFLUOCINOLONE CRE NIACIN Unapproved DrugFLUOPAR KIT LISTFLUORABON DRO Unapproved DrugFLUORE-BENOX SOL 0.25-0.4 Diagnostic AgentFLUORESCEIN/ SOL PROPARAC Diagnostic AgentFLUORESCITE INJ 10% OP Diagnostic AgentFLUORID SENS PST 1.1-5% Not properly listed with FDAFLUORIDE CHW 0.25MG F Unapproved DrugFLUORIDE CHW 0.5MG F Unapproved DrugFLUORIDE CHW 1MG F Unapproved DrugFLUORIDEX CON DLY REN Not properly listed with FDAFLUORIDEX PST 1.1% Unapproved DrugFLUOR-I-STRI TES 1MG OP Diagnostic AgentFLUORITAB CHW 0.25MG F Unapproved DrugFLUORITAB CHW 0.5MG F Unapproved DrugFLUORITAB CHW 1MG F Unapproved DrugFLUORITAB CHW 2.2MG Unapproved DrugFLUORITAB DRO 0.125MG Unapproved DrugFLUOVIX PAK 0.1% LISTFLUOVIX PLUS PAK 0.1% LISTFLURA-DROPS DRO 0.25MG F Unapproved DrugFLURA-SAFE SOL Diagnostic AgentFLUROX SOL OP Diagnostic AgentFLUSH SYRING INJ 0.9% Not properly listed with FDAFLUZONE HD INJ PF 18-19 Influenza Vaccine
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
FLUZONE HD INJ PF 19-20 Influenza VaccineFLUZONE HD INJ PF 20-21 Influenza vaccineFLUZONE QUAD INJ 2018-19 Influenza VaccineFLUZONE QUAD INJ 2019-20 Influenza VaccineFLUZONE QUAD INJ 2020-21 Influenza VaccineFOAMIL LIQ Not properly listed with FDAFOLBEE TAB Vitamin/MineralFOLBEE PLUS TAB Vitamin/MineralFOLBEE PLUS TAB CZ Vitamin/MineralFOLBIC RF TAB Vitamin/MineralFOLET DHA PAK Vitamin/MineralFOLET ONE CAP 38-1-225 Vitamin/MineralFOLGARD OS TAB Vitamin/MineralFOLGARD RX TAB Vitamin/MineralFOLIC ACID INJ 50/10ML Vitamin/mineralFOLIC ACID INJ 5MG/ML Vitamin/MineralFOLIC ACID TAB 1000MCG Vitamin/MineralFOLIC ACID TAB 1MG Vitamin/MineralFOLIC D3 CAP Vitamin/mineralFOLICA-V CAP Vitamin/MineralFOLIC-K CAP Vitamin/MineralFOLI-D TAB Vitamin/MineralFOLIKA-D TAB 1-5000 Vitamin/MineralFOLIKA-T TAB Vitamin/MineralFOLIKA-V TAB Vitamin/MineralFOLITE TAB Dietary SupplementFOLIVANE-F CAP Vitamin/MineralFOLIVANE-OB CAP Vitamin/MineralFOLIXAPURE TAB 1-5000 Vitamin/MineralFOLLISTIM AQ INJ 300UNIT Fertility AgentFOLLISTIM AQ INJ 600UNIT Fertility AgentFOLLISTIM AQ INJ 900UNIT Fertility AgentFOLPLEX 2.2 TAB Vitamin/MineralFOLTANX TAB Vitamin/MineralFOLTANX RF CAP Vitamin/MineralFOLTRATE TAB Vitamin/MineralFOLTREXYL TAB Unapproved DrugFOLTRIN CAP Vitamin/MineralFOLTX TAB Vitamin/MineralFOLVIK-D TAB Vitamin/mineralFOLVITE-D TAB Dietary SupplementFOOD COLOR LIQ BLUE Not properly listed with FDAFORANE SOL General AnestheticFORAXA EMU Surgical Supply/MedicalFORMADON SOL Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
FORMALDEHYDE SOL 10% Unapproved DrugFORMALDEHYDE SOL 37% Unapproved DrugFORMA-RAY SOL 20% Unapproved DrugFORTAVIT CAP Vitamin/MineralFOSTEUM CAP Medical FoodFOSTEUM PLUS CAP Medical FoodFOVEX CAP Medical FoodFREEDOM CRE DERMA-D Not properly listed with FDAFREEDOM CRE DERMA-N Not properly listed with FDAFROTEK CRE 10% Not properly listed with FDAFUL-GLO TES 0.6MG OP Diagnostic AgentFUL-GLO TES 1MG OP Diagnostic AgentFUSARIUM INJ 1:10 Non-standardized allergenicFUSARIUM EXT SOL 1:20 Non-standardized allergenicFUSION PAK SPRINKLE Vitamin/MineralGABA INJ 100MG/ML Unapproved DrugGABA/NAPROX CRE M-P TRAN Not properly listed with FDA GABACAINE PAK LISTGABADONE CAP Medical FoodGABAPAL PAK LISTGADAVIST INJ 1MMOL/ML Diagnostic AgentGALAXTRA POW Not properly listed with FDAGALLIUM 67 SOL 13.2MCI Diagnostic AgentGALLIUM 67 SOL 19.8MCI Diagnostic AgentGALLIUM 67 SOL 6.6MCI Diagnostic AgentGALLIUM 67 SOL 8.8MCI Diagnostic AgentGALZIN CAP 25MG Vitamin/MineralGALZIN CAP 50MG Vitamin/MineralGANIRELIX AC INJ 250/0.5 Fertility AgentGAPEAUM CRE BUDIBAC Bulk IngredientGASTROGRAFIN SOL 66-10% Diagnostic AgentGATIFL-DEXAM SOL 0.5-0.1% Unapproved DrugGAUZE SPONGE PAD 4X4 12PL Not properly listed with FDAGEBAUERS SPR AER /STRETCH Not properly listed with FDAGELCLAIR GEL DeviceGELFILM MIS OP Not properly listed with FDAGEL-FLOW KIT Not properly listed with FDAGELFOAM-JMI KIT POWDER Not properly listed with FDAGELFOAM-JMI KIT SPONGE Not properly listed with FDAGELX GEL Surgical Supply/MedicalGEN7T LOT 3.5% Unapproved DrugGEN7T PAD 3.5% Unapproved DrugGEN7T PLUS LOT 3.5-7% Unapproved DrugGEN7T PLUS PAD 3.5-7% Unapproved DrugGENADUR KIT Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
GENADUR LIQ Not properly listed with FDAGENICIN TAB VITA-D Dietary SupplementGENICIN TAB VITA-Q Vitamin/MineralGENICIN TAB VITA-S Vitamin/MineralGERMAN INJ COCKROAC Non-standardized allergenicGHRP2/ SERMO INJ 15-9MG Unapproved DrugGHRP2/GHRP6 INJ SERMOREL Unapproved DrugGHRP2/GHRP6 INJ SERMOREL Unapproved DrugGHRP2/GHRP6 INJ SERMOREL Unapproved DrugGHRP2/SERMOR INJ 1.8-3MG Unapproved DrugGHRP2/SERMOR INJ 3-3MG Unapproved DrugGHRP2/SERMOR INJ 4.5-4.5 Unapproved DrugGIALAX KIT LISTGILPHEX TR TAB 10-388MG Unapproved DrugGILTUSS LIQ Cough/ColdGILTUSS PED LIQ Cough/ColdGILTUSS TR TAB Cough/ColdGILTUSS TR TAB Cough/ColdGLEOLAN SOL 1500MG Diagnostic AgentGLOFIL-125 INJ 0.1% Diagnostic AgentGLOSTRIPS MIS 1MG OP Diagnostic AgentGLUCAGEN INJ 1MG Diagnostic AgentGLUCAGON INJ 1MG Diagnostic AgentGLUTATHIONE INJ 200MG/ML Unapproved DrugGLUTATHIONE INJ 6GM/30ML Unapproved DrugGLYCINE INJ 50MG/ML Unapproved DrugGLYCINE SOL 1.5% IRR Not properly listed with FDAGLYCOPYRROLA INJ 0.6/3ML Unapproved DrugGLYCOPYRROLA INJ 1MG/5ML Unapproved DrugGLYTAC COMPL BAR 10PE Not properly listed with FDAGLYTACTIN LIQ RES/LITE Not properly listed with FDAGLYTACTIN LIQ RESTORE Not properly listed with FDAGLYTACTIN LIQ RTD 10 Not properly listed with FDAGLYTACTIN LIQ RTD 15 Not properly listed with FDAGLYTACTIN PAK SWIRL 15 Not properly listed with FDAGLYTACTIN POW APPLE Dietary Supplement GLYTACTIN POW BD 20/20 Not properly listed with FDAGLYTACTIN POW BLD 10PE Not properly listed with FDAGLYTACTIN POW BLD PKU Not properly listed with FDAGLYTACTIN POW PUNCH Dietary Supplement GLYTACTIN POW RESTOR 5 Not properly listed with FDAGLYTACTIN POW RESTOR10 Not properly listed with FDAGLYTACTIN POW TROPICAL Dietary Supplement GLYTACTIN 15 LIQ RTD LITE Not properly listed with FDAGOLDENROD SOL 1:20 Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
GONAL-F INJ 1050UNIT Fertility AgentGONAL-F INJ 450UNIT Fertility AgentGONAL-F RFF INJ 300/0.5 Fertility AgentGONAL-F RFF INJ 450/0.75 Fertility AgentGONAL-F RFF INJ 75UNIT Fertility AgentGONAL-F RFF INJ 900/1.5 Fertility AgentGORDONS UREA OIN 40% Unapproved DrugGPL PAK PAK LISTGRAFCO SILVR MIS NIT APPL Unapproved DrugGRASS POLLEN SOL MIX/KORT LISTGREEN GLO MIS 1.5MG Diagnostic AgentHACKBERRY EX SOL 1:20 Non-standardized allergenicHALUCORT GEL DeviceHC PRAMOXINE CRE 1-1% Unapproved DrugHC PRAMOXINE CRE 2.5-1% DESIHC/IODOQUIN CRE KETOCON Unapproved DrugHCG INJ 12000UNT Unapproved DrugHCG INJ 50000UNT Unapproved DrugHCG INJ 6000UNT Unapproved DrugHC-LIDOCAINE CRE 1-1% Not properly listed with FDAHCU EASY TAB Not properly listed with FDAHEALON INJ 10MG/ML DeviceHEALON GV INJ 14MG/ML DeviceHEALON PRO INJ 10MG/ML Not properly listed with FDA HEALON5 INJ 23MG/ML DeviceHEALON5 PRO INJ 23MG/ML Not properly listed with FDA HELIXATE FS INJ 1000UNIT Blood ComponentHELIXATE FS INJ 2000UNIT Blood ComponentHELIXATE FS INJ 250UNIT Blood ComponentHELIXATE FS INJ 3000UNIT Blood ComponentHELIXATE FS INJ 500UNIT Blood ComponentHEMATINIC/FA TAB Vitamin/MineralHEMATRON-AF TAB Vitamin/MineralHEMENATAL OB MIS + DHA Vitamin/MineralHEMLIBRA INJ 105/0.7 Blood ComponentHEMLIBRA INJ 150/ML Blood ComponentHEMLIBRA INJ 30MG/ML Blood ComponentHEMLIBRA INJ 60/0.4 Blood ComponentHEMMOREX-HC SUP 25MG Unapproved DrugHEMMOREX-HC SUP 30MG Unapproved DrugHEMOCYTE-F TAB Vitamin/MineralHEMOFIL M INJ 1000UNIT Blood ComponentHEMOFIL M INJ 1700UNIT Blood ComponentHEMOFIL M INJ 250UNIT Blood ComponentHEMOFIL M INJ 500UNIT Blood Component
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
HEPAGAM B INJ Hepatitis B VaccineHEPARIN LOCK INJ 100/ML Not properly listed with FDAHEPARIN LOCK INJ 10UNT/ML Not properly listed with FDAHEPARIN LOCK INJ 1UNIT/ML Not properly listed with FDAHEPARIN LOCK KIT 100/ML Not properly listed with FDAHEPATOLITE KIT 99M Diagnostic AgentHEPMED KIT Not properly listed with FDAHISTATROL INJ 0.275/ML Diagnostic AgentHISTATROL INJ 2.75/ML Diagnostic AgentHOMACTIN AA LIQ PLUS Not properly listed with FDAHOMATROPAIRE SOL 5% OP Unapproved DrugHOMATROPINE SOL 5% OP Unapproved DrugHOME PAP KIT Diagnostic AgentHONEY BEE INJ 1100MCG Non-standardized allergenicHONEY BEE INJ 120MCG Non-standardized allergenicHORMEL ALLERGY ANTIGEN Not properly listed with FDAHORMONE BASE CRE NIOSOMES Not properly listed with FDAHORMONE HEAV CRE NIOSOMES Not properly listed with FDAHORNET VENOM INJ 1300MCG Non-standardized allergenicHORNET VENOM INJ 550MCG Non-standardized allergenicHORSE EPITHE INJ 1:10 Non-standardized allergenicHORSE EPITHE INJ 1:20 Non-standardized allergenicHPR AER LISTHPR PLUS AER LISTHPR PLUS CRE LISTHPR PLUS KIT DeviceHPR PLUS MB KIT HYDROGEL LISTHUMATE-P SOL 2400UNIT Blood ComponentHUMATE-P SOL 250-600 Blood ComponentHUMATE-P SOL 500-1200 Blood ComponentHYALGAN INJ 20MG/2ML Surgical Supply/MedicalHYALU/NIACIN CRE TACROLIM Unapproved DrugHYALU/NIACIN CRE TRETIN Unapproved DrugHYALU/NIACIN CRE TRETIN Unapproved DrugHYALU/NIACIN CRE TRETIN Unapproved DrugHYALUCIL-4 CRE 2-4% Not properly listed with FDAHYALURONATE GEL 0.2% Unapproved DrugHYALURONIC EMU HYDROQUI CosmeticHYCAMTIN CAP 0.25MG Oral drug for cancer; infusion available under Part BHYCAMTIN CAP 1MG Oral drug for cancer; infusion available under Part BHYCLODEX SOL 0.012% Not properly listed with FDAHYCODAN SYP 5-1.5/5 LISTHYD POL/CPM SUS 10-8/5ML Cough/ColdHYDR/CPM/PSE LIQ 5-4-60MG Cough/ColdHYDRFRA BLUE PAD RDY 2.5" Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
HYDRFRA BLUE PAD RDY 4X5" Not properly listed with FDAHYDRFRA BLUE PAD RDY 8X8" Not properly listed with FDAHYDRFRA MRF PAD 2"X2.75" Not properly listed with FDAHYDRO 35 AER Unapproved DrugHYDRO 40 AER FOAM Unapproved DrugHYDRO/HC/TRE EMU CosmeticHYDRO/HC/TRE EMU CosmeticHYDRO/HC/TRE EMU CosmeticHYDRO/HC/TRE EMU CosmeticHYDRO/HC/TRE EMU CosmeticHYDRO/HC/TRE EMU CosmeticHYDROC IODO CRE 1% Unapproved DrugHYDROC IODO CRE 1-1% Unapproved DrugHYDROC/GUAIF SOL 2.5-200 LISTHYDROC/HOMAT TAB 5-1.5MG Cough/ColdHYDROCOD/HOM SYP 5-1.5/5 Cough/ColdHYDROCORT CRE IODOQUIN DESIHYDROCORT CRE KETOCON Unapproved DrugHYDROCORT AC SUP 25MG DESIHYDROCORT AC SUP 30MG DESIHYDROCORT/ CRE IODOQUIN DESIHYDROFERA PAD 4"X4" Not properly listed with FDAHYDROFERA PAD BLUE 2X2 Not properly listed with FDAHYDROFERA PAD BLUE 4X4 Not properly listed with FDAHYDROFERA PAD BLUE 6X6 Not properly listed with FDAHYDROFERA PAD BLUE 9MM Not properly listed with FDAHYDROFERA PAD MRF 2.5" Not properly listed with FDAHYDROFERA PAD MRF4"X4" Not properly listed with FDAHYDROFRA MRF PAD 2-1/4X8" Not properly listed with FDAHYDROG WOUND MIS 3" DISK Not properly listed with FDAHYDROG WOUND MIS 4-3/4" Not properly listed with FDAHYDROGEL GEL Not properly listed with FDAHYDROGEL DRE PAD 2"X3" Surgical Supply/MedicalHYDROGEL DRE PAD 4"X5" Surgical Supply/MedicalHYDROGEL GAU PAD 2"X2" Not properly listed with FDAHYDROGEL GAU PAD 4"X4" Not properly listed with FDAHYDROGEL GAU PAD 4"X8" Not properly listed with FDAHYDROGEN PER SOL 30% Not properly listed with FDAHYDROMET SYP 5-1.5/5 Cough/ColdHYDROMO/NACL INJ 20/100ML OTCHYDROMORPHON SUP 3MG Not properly listed with FDAHYDROQUIN/HC EMU 6-0.5% CosmeticHYDROQUINONE CRE 4% CosmeticHYDROQUINONE CRE 4% TR CosmeticHYDROQUINONE EMU 4% Cosmetic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
HYDROQUINONE EMU 6% CosmeticHYDROQUINONE EMU 8% CosmeticHYDROXOCOBAL INJ 1000MCG Not properly listed with FDAHYGEL GEL 2.5% Surgical Supply/MedicalHYLAFEM SUP Unapproved DrugHYLAGUARD CRE Not properly listed with FDA HYLAMIX CRE Not properly listed with FDAHYLATOPIC AER PLUS DeviceHYLATOPIC CRE PLUS DeviceHYLATOPIC LOT PLUS Not properly listed with FDAHYLAVITE TAB Vitamin/MineralHYLAZINC TAB Vitamin/MineralHYLENEX INJ 150 UNIT LISTHYLINATE LOT 0.1% Unapproved DrugHYOLEV MB TAB 81MG Unapproved DrugHYOPHEN TAB Unapproved DrugHYOSCYAMINE DRO 0.125/ML Unapproved DrugHYOSCYAMINE ELX 0.125/5 Unapproved DrugHYOSCYAMINE INJ 0.5MG/ML Unapproved DrugHYOSCYAMINE SUB 0.125MG Unapproved DrugHYOSCYAMINE TAB 0.125MG Unapproved DrugHYOSCYAMINE TAB 0.125MG Unapproved DrugHYOSCYAMINE TAB 0.375 ER Unapproved DrugHYOSCYAMINE TAB 0.375 SR Unapproved DrugHYOSYNE DRO 0.125/ML Unapproved DrugHYOSYNE ELX 0.125/5 Unapproved DrugHYPERHEP B INJ S/D Hepatitis B VaccineHYPERSAL NEB 3.5% Not properly listed with FDAHYPERSAL NEB 7% Not properly listed with FDAHYPER-SAL NEB 7% Not properly listed with FDAHYPERTENSA CAP Medical FoodHYPNOSOM TAB Dietary SupplementHYPOCYN SPR LISTHYRONAN KIT Unapproved DrugIBU 600-EZS KIT 600MG LISTIBU/MINREX PAK Not properly listed with FDAIBUPAK KIT LISTIBUPROFEN CRE 10% Bulk IngredientIC GREEN INJ 25MG Diagnostic AgentID NOW KIT COVID-19 Diagnostic AgentID NOW CONTR KIT COVID-19 Diagnostic AgentIDELVION SOL 1000UNIT Blood ComponentIDELVION SOL 2000UNIT Blood ComponentIDELVION SOL 250UNIT Blood ComponentIDELVION SOL 3500UNIT Blood Component
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
IDELVION SOL 500UNIT Blood ComponentIFE-PG20 INJ 20MCG/ML Erectile DysfunctionILIDERM SPR Not properly listed with FDA IMIOXIA CRE Not properly listed with FDA IMIQ/LEV/NIA GEL 5-1-2% Unapproved DrugIMIQ/LEVOCET GEL TRETINO Unapproved DrugINATAL GT TAB Vitamin/MineralINAVIX PAK 75-0.025 LISTINDICLOR INJ Diagnostic AgentINDIGO CARMI INJ 8MG/ML Diagnostic AgentINDIOMIN MB CAP 120MG Unapproved DrugINDIUM IN111 INJ DTPA Diagnostic AgentINDIUM IN111 INJ OXYQUINO Diagnostic AgentINDOCYANINE INJ 25MG Diagnostic AgentINFED INJ 50MG/ML Vitamin/MineralINFLAMMACIN MIS 75-0.025 LISTINFLAMMA-K KIT Not properly listed with FDAINFLAMMATION PAK REDUCTIO LISTINFLATHERM PAK LISTINFUVITE INJ Vitamin/MineralINFUVITE INJ ADULT Vitamin/MineralINFUVITE INJ PEDIATRI Vitamin/MineralINJECTAFER INJ 750/15ML Not properly listed with FDAINOVA KIT 4% Not properly listed with FDAINTEGRA F CAP Vitamin/MineralINULIN INJ 100MG/ML Diagnostic AgentIODINE SOL STRONG Not properly listed with FDAIODINE TIN 2% Not properly listed with FDAIODOFLEX PAD PAD Surgical Supply/MedicalIODOFORM STR MIS 1/2"X15' Not properly listed with FDAIODOFORM STR MIS 1/4"X15' Not properly listed with FDAIODOFORM STR MIS 2"X15' Not properly listed with FDAIODOQU/HC/ GEL ALOE Not properly listed with FDAIODOQU-HC GEL ALOE Unapproved DrugIODOQUIMEZ CRE 1-1.9% Not properly listed with FDAIODOSORB GEL Not properly listed with FDAIODOSORB GEL 0.9% Not properly listed with FDAIOHEXOL SOL 240MG/ML Diagnostic AgentIOHEXOL SOL 300MG/ML Diagnostic AgentIPAMORELIN INJ 15MG ACE Unapproved DrugIPAMORELIN INJ 6MG ACET Unapproved DrugISOFLURANE SOL General AnestheticISOMETH/CAFF TAB /APAP DESIISOMETH/CAFF TAB /APAP DESIISOP ALCOHOL SOL 70% Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ISOPROPANOL SOL 70% LISTISOSULFAN INJ BLUE 1% Diagnostic AgentISOVACTIN AA LIQ PLUS Not properly listed with FDAISOVUE-200 INJ 41% Diagnostic AgentISOVUE-250 INJ 51% Diagnostic AgentISOVUE-250 INJ 51%MLTPK Diagnostic AgentISOVUE-300 INJ 61% Diagnostic AgentISOVUE-300 INJ 61%MLTPK Diagnostic AgentISOVUE-370 INJ 76% Diagnostic AgentISOVUE-370 INJ 76%MLTPK Diagnostic AgentISOVUE-M 200 INJ 41% Diagnostic AgentISOVUE-M 300 INJ 61% Diagnostic AgentISOXSUPRINE TAB 10MG DESIISOXSUPRINE TAB HCL 20MG DESIITHOXIA CRE Not properly listed with FDAIV NOVICE PK KIT Not properly listed with FDAIVER/METR/NI GEL 1-1-4% Unapproved DrugIXINITY INJ 1000UNIT Blood ComponentIXINITY INJ 1500UNIT Blood ComponentIXINITY INJ 2000UNIT Blood ComponentIXINITY INJ 250UNIT Blood ComponentIXINITY INJ 3000UNIT Blood ComponentIXINITY INJ 500UNIT Blood ComponentJIVI INJ 1000UNIT Blood ComponentJIVI INJ 2000UNIT Blood ComponentJIVI INJ 3000UNIT Blood ComponentJIVI INJ 500 UNIT Blood ComponentJNT/TUNNEL/ KIT TRIGGER LISTJOHNSON SOL GRASS Non-standardized allergenicJTT PHYSICNS KIT LISTJUNE GRASS SOL POLLEN Non-standardized allergenicK CITRATE SOL CITR ACD Unapproved DrugK.B.G.L IN CRE TERODERM Bulk IngredientK/NA CITRATE SOL CITR ACD Unapproved DrugKAMDOY EMU DeviceKAPOK SOL 1:20 Non-standardized allergenicKATARYA EMU CosmeticKATARYAXN EMU CosmeticKAXM EMU CosmeticKCENTRA KIT 1000UNIT Blood ComponentKCENTRA KIT 500UNIT Blood ComponentKEDBUMIN INJ 25% Blood ComponentK-EFFERVESCE TAB 25MEQ EF Unapproved DrugKEIDO EMU CosmeticKELARX GEL Device
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
KERAGEL GEL WOUND DeviceKERAGELT GEL DeviceKERALAC CRE 47% Unapproved DrugKERALYT GEL 6% Unapproved DrugKERALYT KIT SCALP 6% Unapproved DrugKERAMATRIX MIS 10X10CM DeviceKERAMATRIX MIS 5X5CM DeviceKERLIX AMD MIS BANDAGE Not properly listed with FDAKETALAR INJ 100MG/ML General AnestheticKETALAR INJ 10MG/ML General AnestheticKETALAR INJ 50MG/ML General AnestheticKETAMIN/NACL INJ 10MG/ML General AnestheticKETAMIN/NACL INJ 50MG/5ML General AnestheticKETAMIN/NACL SOL 100/10ML General AnestheticKETAMIN/NACL SOL 20MG/2ML General AnestheticKETAMINE INJ 100MG/ML General AnestheticKETAMINE INJ 10MG/ML General AnestheticKETAMINE INJ 50MG/ML General AnestheticKETAMINE HCL INJ 0.6MG/ML gENeral AnestheticKETAMINE HCL INJ 100/2ML General AnestheticKETAMINE HCL INJ 1MG/ML General AnestheticKETAMINE HCL INJ 30MG/3ML General AnestheticKETAMINE HCL INJ 50MG/5ML General AnestheticKETAMINE HCL INJ 60/20ML General AnestheticKETAMINE HCL SOL General AnestheticKETAMINE HCL SOL 20MG/2ML General AnestheticKETAMINE HCL SOL 50MG/ML General AnestheticKETAMINE HCL TRO 100MG General AnestheticKETARYA EMU CosmeticKETODAN KIT 2% LISTKETOPHENE CRE RAPIDPAQ Unapproved DrugKETOPROFEN CRE 5% KIT Not properly listed with FDAKETOROCAINE KIT -L LISTKETOROCAINE KIT -LM LISTKETOROLAC GEL 2% Not properly listed with FDAKETOVIE LIQ Not properly listed with FDAKETOVIE LIQ CHOCOLAT Not properly listed with FDAKETOVIE LIQ PEPTIDE Not properly listed with FDAKETOVIE LIQ VANILLA Not properly listed with FDAKEVARYA EMU CosmeticKEXM EMU CosmeticKEYA EMU CosmeticKINEVAC INJ 5MCG Diagnostic AgentKIVIK EMU DeviceKLOR-CON/EF TAB 25MEQ FR Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
KOATE INJ 1000UNIT Blood ComponentKOATE INJ 250UNIT Blood ComponentKOATE INJ 500 UNIT Blood ComponentKOATE-DVI INJ 1000UNIT Blood ComponentKOATE-DVI INJ 250UNIT Blood ComponentKOATE-DVI INJ 500UNIT Blood ComponentKOCHIA EXTRA INJ 1:20 Non-standardized allergenicKOGENATE FS INJ 1000UNIT Blood ComponentKOGENATE FS INJ 2000UNIT Blood ComponentKOGENATE FS INJ 250UNIT Blood ComponentKOGENATE FS INJ 3000UNIT Blood ComponentKOGENATE FS INJ 500UNIT Blood ComponentKOSHR PRENAT TAB 30-1MG Vitamin/MineralKOVALTRY INJ 1000UNIT Blood ComponentKOVALTRY INJ 2000UNIT Blood ComponentKOVALTRY INJ 250UNIT Blood ComponentKOVALTRY INJ 3000UNIT Blood ComponentKOVALTRY INJ 500UNIT Blood ComponentK-PHOS TAB Unapproved DrugK-PHOS TAB NEUTRAL Unapproved DrugK-PHOS TAB NO 2 Unapproved DrugK-PRIME TAB 25MEQ EF Unapproved DrugKRISGEL 100 GEL Not properly listed with FDAKUTARYAXM EMU CosmeticKUTARYAXMPA EMU CosmeticKUTEA EMU CosmeticKUVARYA EMU CosmeticKUVARYE EMU CosmeticKUXM EMU CosmeticK-VESCENT TAB 25MEQ EF Unapproved DrugKYBELLA INJ CosmeticKYMRIAH SUS Covered under Part B; Blood ComponentL.E.T. GEL Not properly listed with FDALACTIC ACID CRE /VIT E Unapproved DrugLACTIC ACID CRE E Unapproved DrugLACTIC ACID CRE NIACIN Unapproved DrugLACTIC ACID LOT 10% Unapproved DrugLACTOJEN CAP Dietary Supplement LAMBS SOL QUARTERS Non-standardized allergenicLANOLIN OIN Unapproved DrugLANOLIN ANHY OIN Not properly listed with FDALANSOPRAZOLE SUS 3MG/ML Bulk IngredientL-ARGININE INJ 200MG/ML Unapproved DrugLATISSE SOL 0.03% CosmeticLAVARE WOUND GEL WASH Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
L-CARNITINE INJ 500MG/ML Unapproved DrugLDL CARE POW Not properly listed with FDALDO PLUS GEL 4% LISTLECITHIN GEL Not properly listed with FDALECITHIN GRA Not properly listed with FDALENSCALE INJ 1:20 Non-standardized allergenicLETS KIT Unapproved DrugLEVA SET KIT 2.5-2.5% LISTLEVATIO PAD 0.3-5% Unapproved DrugLEVBID TAB 0.375 ER Unapproved DrugLEVICYN GEL Not properly listed with FDALEVICYN SOL DERMAL Not properly listed with FDALEVITRA TAB 10MG Erectile DysfunctionLEVITRA TAB 2.5MG Erectile DysfunctionLEVITRA TAB 20MG Erectile DysfunctionLEVITRA TAB 5MG Erectile DysfunctionLEVO/LIOTHYR TAB 120MG Unapproved DrugLEVO/LIOTHYR TAB 15MG Unapproved DrugLEVO/LIOTHYR TAB 30MG Unapproved DrugLEVO/LIOTHYR TAB 60MG Unapproved DrugLEVO/LIOTHYR TAB 90MG Unapproved DrugLEVOMEFOLATE CAP ALGAL 15-90.314 MG Not properly listed with FDALEVOMEFOLATE CAP ALGAL 7.5-90.314 MG Not properly listed with FDALEVOMEFOLATE CAP DHA Vitamin/MineralLEVSIN INJ 0.5MG/ML Unapproved DrugLEVSIN TAB 0.125MG Unapproved DrugLEVSIN/SL SUB 0.125MG Unapproved DrugLEXISCAN INJ 0.4MG Diagnostic AgentLEXIXRYL PAK 1.5% LISTLIDO BDK KIT Not properly listed with FDALIDO GB-300 PAK LISTLIDO/EPI INJ 0.5% Not properly listed with FDALIDO/EPI INJ 1.5% Not properly listed with FDALIDO/EPI INJ 2% Not properly listed with FDALIDO/EPI INJ 2% Not properly listed with FDALIDO/EPI 1%- INJ 1:100000 Not properly listed with FDALIDO/PRILOCN KIT 2.5-2.5% Not properly listed with FDALIDO/TETRA CRE 23-7% Unapproved DrugLIDOCAIN/EPI INJ 2% LISTLIDOCAINE CRE 10% Bulk IngredientLIDOCAINE CRE 3% Unapproved DrugLIDOCAINE CRE 3.88% Unapproved DrugLIDOCAINE CRE 5% Bulk IngredientLIDOCAINE LOT 3% Unapproved DrugLIDOCAINE HC CRE 4.12% Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
LIDOCAINE/HC CRE 3%-0.5% Unapproved DrugLIDOCAINE/HC KIT 2-2% Unapproved DrugLIDOCAINE/HC KIT 3%-0.5% Unapproved DrugLIDOCAINE/HC KIT 3%-1% Unapproved DrugLIDOCAINE/HC KIT 3-2.5% Unapproved DrugLIDOCAINE/PH SOL 1-1.5% Unapproved DrugLIDOCANNA PAD 4% Unapproved DrugLIDOCORT CRE 3-0.5% Unapproved DrugLIDO-EP-TETR SOL Unapproved DrugLIDO-HYDRO GEL 2.8-0.55 Unapproved DrugLIDO-K LOT 3% Not properly listed with FDALIDOLOG KIT LISTLIDOMAR INJ Not properly listed with FDALIDOMARK 1/5 KIT LISTLIDOMARK 2/5 KIT LISTLIDOPAC KIT 5% Not properly listed with FDALIDO-PHENYL INJ 1-1.5% Unapproved DrugLIDOPIN CRE 3% Unapproved DrugLIDOPIN CRE 3.25% Unapproved DrugLIDOPRIL KIT 2.5-2.5% LISTLIDOPRIL XR KIT 2.5-2.5% LISTLIDO-PRILO KIT 2.5-2.5% LISTLIDOPURE KIT 5% LISTLIDORX GEL 3% Not properly listed with FDALIDOSOL-HC CRE 3-0.5% Not properly listed with FDALIDO-SORB LOT 3% Unapproved DrugLIDOSTREAM KIT 5% & 10% LISTLIDOTHOL GEL 4.5-5% Not properly listed with FDALIDOTHOL PAD 4.5-5% Unapproved DrugLIDOTIN PAK LISTLIDOTRAL CRE 3.88% Unapproved DrugLIDOTRANS 5 KIT 5% LISTLIDOTREX GEL 2% Not properly listed with FDALIDOVEX CRE 3.75% Unapproved DrugLIDOVIX KIT 75MG-5% Unapproved DrugLIDOVIX L KIT 5% LISTLIDOZION LOT 3% Unapproved DrugLIDTOPIC MAX CRE 10% Not properly listed with FDALIFEMS NALOX INJ 2MG/2ML LISTLIMBREL CAP 250MG Medical FoodLIMBREL CAP 500MG Medical FoodLIMBREL250 CAP 250-50MG Medical FoodLIMBREL500 CAP 500-50MG Medical FoodLIPICHOL 540 CAP Not properly listed with FDALIPIODOL INJ Diagnostic Agent
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
LIPO INJ 50-50-25 Unapproved DrugLIPO CREAM CRE BASE Not properly listed with FDALIPO-B INJ Vitamin/MineralLIPO-C INJ Unapproved DrugLIPOCREAM CRE BASE Not properly listed with FDALIPOFOAM RX AER Not properly listed with FDALIPOLAYER CRE Not properly listed with FDALIPOPEN ABSO CRE ENHANCNG Not properly listed with FDALIPOPEN ULTR CRE BASE Not properly listed with FDALIPOSOMAL CRE HEAVY Not properly listed with FDALIPOSOMAL CRE REGULAR Not properly listed with FDALIPOZYME CRE Not properly listed with FDALIPRITIN PAK LISTLIPRITIN II PAK LISTLIPROZONEPAK KIT 2.5-2.5% LISTLIQUIHEP KIT 500UNIT Diagnostic AgentLIQUIHEP II KIT 500UNIT Diagnostic AgentLIQUILIFT KIT TRACE Not properly listed with FDALIQUIVIDA KIT HYDRATIO LISTLISSAMINE GR TES 1.5MG Diagnostic AgentLISTER-V CAP Not properly listed with FDALITH HEPARIN KIT 100UNIT Diagnostic AgentLITH HEPARIN KIT 500UNIT Diagnostic AgentLITH HEPARIN KIT 70UNIT Diagnostic AgentLIVIXIL PAK KIT 2.5-2.5% LISTL-LYSINE HCL INJ 100MG/ML Unapproved DrugL-METHYL- TAB B6-B12 Vitamin/MineralL-METHYLFOLA CAP ALGAL Not properly listed with FDAL-METHYLFOLA CAP FORM 15 Not properly listed with FDAL-METHYLFOLA CAP FORM 7.5 Not properly listed with FDAL-METHYLFOLA CAP FORTE Not properly listed with FDAL-METHYLFOLA CAP FORTE 15 Not properly listed with FDAL-METHYLFOLA TAB 15MG Medical FoodL-METHYLFOLA TAB 7.5MG Medical FoodL-METHYL-MC TAB Vitamin/MineralL-METHYL-MC TAB NAC Unapproved DrugLMR PLUS KIT LISTLMTHF/B6/B12 TAB Vitamin/MineralLOMAIRA TAB 8MG Anorexic, Anti-obesity AgentLOPROX KIT 0.77% LISTLORID TAB Vitamin/MineralLORMATE CAP Dietary Supplement LORVATUS KIT PHARMAPA LISTLOUTREX CRE LISTLOYON SOL Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
LP LITE PAK KIT 2.5-2.5% Unapproved DrugLUGOLS SOL IODINE Unapproved DrugLUGOLS SOL STRONG Unapproved DrugLUKAID GLA EMU 1GM/ML Unapproved DrugLUMASON INJ 60.7-25 Diagnostic AgentLURADROX GEL 0.1% Surgical Supply/MedicalLUVIRA CAP Unapproved DrugLUXAMEND CRE Not properly listed with FDALYDEXA CRE 4.12% Unapproved DrugLYMPHOMYSOT INJ X Not properly listed with FDALYRA DIRECT KIT COV-2 Diagnostic AgentLYRA SARS KIT COV-2 Diagnostic AgentLYSIPLEX TAB PLUS Vitamin/MineralM.V.I PEDIAT INJ Vitamin/MineralM.V.I. ADULT INJ Vitamin/MineralMACRILEN PAK 60MG Diagnostic AgentMACUTEK TAB Not properly listed with FDAMAGNEBIND TAB 400 Vitamin/MineralMAGNESIUM CL INJ 20% Unapproved DrugMAGNESIUM SULFATE INJ 1000 MG/1.6ML Unapproved DrugMAGNESIUM SULFATE INJ 2000 MG/3.2ML Unapproved DrugMAGNESIUM SULFATE INJ 3000 MG/4.8ML Unapproved DrugMAGNESIUM SULFATE INJ 4000 MG/6.4ML Unapproved DrugMAGNEVIST INJ 46.9% Diagnostic AgentMANGANESE SU INJ 0.1MG/ML Unapproved DrugMARBETA-25 KIT LISTMARBETA-L KIT LISTMARCAINE INJ SPINAL Not properly listed with FDAMARCAINE/EPI INJ 0.25% LISTMARCAINE/EPI INJ 0.25% Not properly listed with FDAMARCAINE/EPI INJ 0.5% LISTMARCAINE/EPI INJ 0.5% Not properly listed with FDAMARDEX-25 KIT LISTMARLIDO KIT LISTMARLIDO-25 KIT LISTMARNATAL-F CAP Vitamin/MineralMARSH ELDER INJ 1:20 Non-standardized allergenicMARVONA KIT 0.5% LISTMAS CARE-PAK KIT 10MG/ML LISTMB HYDROGEL KIT Unapproved DrugMD-76 R INJ Diagnostic AgentMD-GASTROVIE SOL 66-10% Diagnostic AgentME/NAPHOS/MB TAB HYO 1 Unapproved DrugMEADOW FESCU INJ 100000BA Non-standardized allergenicMEBOLIC TAB Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
MEBROFENIN KIT 99M Diagnostic AgentMEDACTIV TAB Anorexic, Anti-obesity AgentMEDCATED DNA KIT COLLECT Diagnostic AgentMEDCATED DNA KIT COLLECT2 Diagnostic AgentMEDIDERM CRE Not properly listed with FDAMEDI-DERM CRE -RX Unapproved DrugMEDI-DERM/L- CRE RX Unapproved DrugMEDIHOL BASE GEL Not properly listed with FDAMEDIHONEY GEL WOUND Not properly listed with FDAMEDIHONEY PAD 2"X2" Not properly listed with FDAMEDIHONEY PAD 3/4"X12" Not properly listed with FDAMEDIHONEY PAD 4"X5" Not properly listed with FDAMEDIHONEY PST WOUND Not properly listed with FDAMEDI-PATCH PAD RX Not properly listed with FDAMEDOLOR PAK KIT 2.5-2.5% LISTMEDROLOAN KIT 40MG/ML LISTMEDROLOAN II KIT 40MG/ML LISTMEDRONATE KIT 99M Diagnostic AgentMEDROX-RX OIN OTC ProductMELALEUCA INJ 1:20 Non-standardized allergenicMELPHALAN TAB 2MG Oral drug for cancer; infusion available under Part BMENOPUR INJ 75UNIT Fertility AgentMENTHO-CAINE KIT 5-8% Not properly listed with FDAMEPHYTON TAB 5MG Vitamin/MineralMESQUITE SOL EXTRACT Non-standardized allergenicMET/KET/OND TRO 3-25-2MG General AnestheticMETAFOLBIC TAB Vitamin/MineralMETAFOLBIC TAB PLUS Vitamin/MineralMETAFOLBIC TAB PLUS RF Vitamin/MineralMETANX CAP Vitamin/MineralMETAXALL CP KIT 0.025% Not properly listed with FDAMETHACHOLINE KIT CHLORIDE Diagnostic AgentMETHAVER CAP Unapproved DrugMETHAZEL CAP Unapproved DrugMETHENAM MAN TAB 1000MG Unapproved DrugMETHENAM MAN TAB 1GM Unapproved DrugMETHENAM MAN TAB 500MG Unapproved DrugMETHIO/INOS/ INJ CHOL/B12 Vitamin/MineralMETHOHEX SOD INJ 100/10ML General AnestheticMETHOHEX SOD SOL 50MG/5ML General AnestheticMETHYL SALIC LIQ Not properly listed with FDAMETHYLCOBALA INJ 10000MCG Unapproved DrugMETHYLCOBALA INJ 10MG/ML Vitamin/MineralMETHYLCOBALA INJ 1MG/ML Vitamin/MineralMETHYLCOBALA INJ 50000MCG Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
METHYLCOBALA INJ 5MG/ML Vitamin/MineralMETHYLFOL/CA TAB ME-CBL Vitamin/MineralMETHYLFOL/ME CAP CBL/P5P Vitamin/MineralMETOPIC CRE 41% Unapproved DrugMETOPIRONE CAP 250MG Diagnostic AgentMETRONIDAZOL SUS 50MG/ML LISTMICROCYN GEL Not properly listed with FDAMICROCYN GEL SKIN/WOU Not properly listed with FDAMICROCYN LIQ Not properly listed with FDAMICROPLEGIA INJ MSA/MSG Not properly listed with FDAMICROVIX LP PAK 2.5-2.5% Unapproved DrugMIDAZO/NACL INJ 100/100 General AnestheticMIDAZOL/D5W SOL 50/50ML General AnestheticMIDAZOL/NACL INJ 50/50ML General anestheticMIDAZOL/NACL SOL 100/100 General AnestheticMIDAZOL/NACL SOL 100/100 General AnestheticMIDAZOL/NACL SOL 25/100ML General AnestheticMIDAZOL/NACL SOL 2MG/2ML General AnestheticMIDAZOL/NACL SOL 50/100ML General AnestheticMIDAZOL/NACL SOL 50/50ML General AnestheticMIDAZOL/NACL SOL 55/55ML General AnestheticMIDAZOL/NACL SOL 5MG/5ML General AnestheticMIDAZOLAM INJ 10/10ML General AnestheticMIDAZOLAM INJ 10MG/2ML General AnestheticMIDAZOLAM INJ 25MG/5ML General AnestheticMIDAZOLAM INJ 2MG/2ML General AnestheticMIDAZOLAM INJ 30MG/30ML General AnestheticMIDAZOLAM INJ 50/10ML General AnestheticMIDAZOLAM INJ 50/50ML General AnestheticMIDAZOLAM INJ 50MG/10 General AnestheticMIDAZOLAM INJ 5MG/5ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM INJ 5MG/ML General AnestheticMIDAZOLAM INJ NACL General AnestheticMIDAZOLAM SOL 100MG General AnestheticMIDAZOLAM SOL 2MG/2ML General AnestheticMIDAZOLAM SUS 1MG/ML General AnestheticMIDAZOLAM SYP 2MG/ML General AnestheticMIDAZOL-NACL INJ General anestheticMIGRAINE MIS PACK LISTMIGRANOW PAK LISTMIMYX CRE Not properly listed with FDAMINERAL OIL HEAVY Not properly listed with FDAMINOX/PROGES SOL TRETIN Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
MINOXIDIL SOL PROGEST Unapproved DrugMITE SOL D.FARINA LISTMITE SOL D.PTERON LISTMITE SOL EXTRACT Non-standardized allergenicMITE SOL EXTRACT Non-standardized allergenicMITOMYCIN SOL 20MG Unapproved DrugMIXED SOL FEATHERS Non-standardized allergenicMIXED SOL RAGWEED Non-standardized allergenicMIXED ASPERG SOL 20000PNU Non-standardized allergenicMIXED VESPID INJ 1650MCG Non-standardized allergenicMIXED VESPID INJ 3900MCG Non-standardized allergenicMIXED VESPID INJ VENOM PR Non-standardized allergenicMIXED VESPID INJ VENOM PR Non-standardized allergenicMKO MELT PK TRO 3-25-2MG General AnestheticMLK F1 KIT LISTMLK F2 KIT LISTMLK F3 KIT LISTMLK F4 KIT LISTMLP A-2 KIT LISTM-NATAL PLUS TAB Vitamin/MineralMODERNA VAC INJ COVID-19 Unapproved DrugMONOCLATE-P INJ 1000UNIT Blood ComponentMONOFERRIC INJ 1000/10 LISTMONONINE INJ 1000UNIT Blood ComponentMONSELS FERR SOL SUBSULF Unapproved DrugMORCIN CRE Unapproved DrugMORGIDOX KIT 1X100MG LISTMORGIDOX KIT 1X50MG LISTMORGIDOX KIT 2X100MG LISTMORPHINE SUL INJ 1MG/ML Unapproved DrugMORPHINE SUL INJ 5MG/5ML Not properly listed with FDAMORPHINE SUL SUP 10MG Not properly listed with FDAMORPHINE SUL SUP 20MG Not properly listed with FDAMORPHINE SUL SUP 30MG Not properly listed with FDAMORPHINE SUL SUP 5MG Not properly listed with FDAMOSQUITO INJ 1:100 Non-standardized allergenicMOUNTAIN SOL CEDAR Non-standardized allergenicMOUSE EPITHE INJ 1:20 Non-standardized allergenicMOUTH WASH LIQ GP Not properly listed with FDAMOUTHWASH LIQ AF Not properly listed with FDAMOUTHWASH LIQ OM Not properly listed with FDAMOXIFLOXACIN INJ 0.3MG Unapproved DrugMOXIFLOXACIN INJ 1MG/ML Not properly listed with FDAMOXIFLOXACIN SOL 1MG/ML Not properly listed with FDAMOXIFLOXACIN SOL 5MG/ML Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
MSUD EASY TAB Not properly listed with FDAMUCOR INJ 1:20 LISTMUCOR EXT INJ 1:10 Non-standardized allergenicMUCOR EXT INJ 1:20 Non-standardized allergenicMUCOSITISRX POW Not properly listed with FDAMUGWORT SOL EXTRACT Non-standardized allergenicMULTI- KIT SPECIALT LISTMULTI VIT/FL CHW 0.25MG Vitamin/MineralMULTI VIT/FL DRO 0.5MG/ML Vitamin/MineralMULTIBASE CRE Not properly listed with FDAMULTIHANCE SOL Diagnostic AgentMULTIPRO CAP Multi-vitamin MULTITRACE-4 INJ Unapproved DrugMULTITRACE-4 INJ CONC Unapproved DrugMULTITRACE-4 INJ NEONATAL Unapproved DrugMULTITRACE-4 INJ PED Unapproved DrugMULTITRACE-5 INJ Unapproved DrugMULTITRACE-5 INJ CONC Unapproved DrugMULTITRACE-5 INJ REGULAR Unapproved DrugMULTIV/FLUOR CHW 0.25-0.3 Vitamin/MineralMULTIV/FLUOR CHW 0.5-0.3 Vitamin/MineralMULTIV/FLUOR CHW 1-0.3MG Vitamin/MineralMULTI-VIT/FE DRO /FL 0.25 Vitamin/MineralMULTIVIT/FL CHW 0.25MG Vitamin/MineralMULTIVIT/FL CHW 0.5MG Vitamin/MineralMULTIVIT/FL CHW 1MG Vitamin/MineralMULTI-VIT/FL DRO /FE 0.25 Vitamin/MineralMULTI-VIT/FL DRO 0.25MG Vitamin/MineralMULTI-VIT/FL DRO 0.5MG/ML Vitamin/MineralMUSE SUP 1000MCG Erectile DysfunctionMUSE SUP 125MCG Erectile DysfunctionMUSE SUP 250MCG Erectile DysfunctionMUSE SUP 500MCG Erectile DysfunctionMYDRIACYL SOL 1% OP Diagnostic AgentMYLERAN TAB 2MG LISTMYNATAL CAP Vitamin/MineralMYNATAL TAB Vitamin/MineralMYNATAL TAB ADVANCE Vitamin/MineralMYNATAL PLUS TAB Vitamin/MineralMYNATAL-Z TAB Vitamin/MineralMYNATE 90 TAB PLUS Vitamin/MineralMYNEPHROCAPS CAP Vitamin/MineralMYNEPHRON CAP Vitamin/MineralMYOVIEW KIT 30ML Diagnostic AgentNA HYDROXIDE SOL 10% Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
NABI-HB INJ Hepatitis B VaccineN-ACETYL-L- CAP CYSTEINE Not properly listed with FDANACL/BACT INJ 0.9%BENZ LISTNAFRINSE CHW 1MG F Unapproved DrugNAFRINSE DRO 0.125MG Unapproved DrugNAFRINSE SOL DAILY Unapproved DrugNAFRINSE DLY SOL /NEUTRAL Unapproved DrugNAFRINSE WK SOL 0.2% Unapproved DrugNALTREXONE IMP Unapproved DrugNAND DEC/TES INJ CYP/EN Unapproved DrugNANDROLONE INJ 200MG/ML Unapproved DrugNAPRO CRE 15% Not properly listed with FDANAPROXEN CRE Bulk IngredientNAPROXEN CRE 10% Bulk IngredientNAPROXEN KIT COMFORT LISTNASCOBAL SPR 500MCG Vitamin/MineralNATACHEW CHW Vitamin/MineralNATACREAM CRE Not properly listed with FDANATALVIT TAB 75-1MG Vitamin/MineralNATELLE ONE CAP Vitamin/MineralNATURAL CRE Not properly listed with FDANATURE THROI TAB 162.5MG Unapproved DrugNATURE-THROI TAB 113.75MG Unapproved DrugNATURE-THROI TAB 130MG Unapproved DrugNATURE-THROI TAB 146.25MG Unapproved DrugNATURE-THROI TAB 16.25MG Unapproved DrugNATURE-THROI TAB 195MG Unapproved DrugNATURE-THROI TAB 260MG Unapproved DrugNATURE-THROI TAB 32.5MG Unapproved DrugNATURE-THROI TAB 325MG Unapproved DrugNATURE-THROI TAB 48.75MG Unapproved DrugNATURE-THROI TAB 65MG Unapproved DrugNATURE-THROI TAB 81.25MG Unapproved DrugNATURE-THROI TAB 97.5MG Unapproved DrugNEBUSAL NEB 3% DeviceNEBUSAL NEB 6% DeviceNEEVO DHA CAP 27-1.13 Vitamin/MineralNEOCERA CRE Not properly listed with FDANEOKE BHB POW Not properly listed with FDANEONATAL TAB COMPLTE Vitamin/MineralNEONATAL 19 TAB Multi-vitamin NEONATAL FE TAB Multi-vitamin w/ ironNEONATAL PLS TAB 27-1MG Vitamin/MineralNEONATAL/DHA MIS Multi-vitamin NEOSALUS AER Device
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
NEOSALUS CRE DeviceNEOSALUS LOT DeviceNEOSALUS CP CRE DeviceNEOSTIG METH INJ 2MG/2ML Not properly listed with FDANEOSTIG METH INJ 4MG/4ML Not properly listed with FDANEOSTIG METH INJ 5MG/5ML Not properly listed with FDANEO-SYNALAR KIT LISTNEOTUSS PLUS LIQ Cough/ColdNEPHPLEX RX TAB Vitamin/MineralNEPHRONEX TAB Vitamin/MineralNEPHRO-VITE TAB RX Vitamin/MineralNESTABS TAB Vitamin/MineralNESTABS ABC MIS Vitamin/MineralNESTABS DHA PAK Vitamin/MineralNESTABS ONE CAP Vitamin/MineralNETSPOT KIT Diagnostic AgentNEUAC KIT 1.2-5% LISTNEULUMEX SUS 0.1% Diagnostic AgentNEURALGO INJ RHEUM Unapproved DrugNEURAPTINE CRE 10% Not properly listed with FDANEURCAINE MIS LISTNEUREPA CAP Not properly listed with FDANEURIN-SL SUB Vitamin/MineralNEUTRASAL POW Not properly listed with FDANEXA PLUS CAP Vitamin/MineralNEXAVIR INJ Unapproved DrugNIACIN/SPIRO GEL TRETINO Unapproved DrugNIACIN/SPIRO GEL TRETINOI Unapproved DrugNIACINAMIDE CRE SULFACET Unapproved DrugNIACINAMIDE CRE TAZAROTE Unapproved DrugNIACINAMIDE CRE TAZAROTE Unapproved DrugNIACINAMIDE CRE TRETINOI Unapproved DrugNIACINAMIDE CRE TRETINOI Unapproved DrugNIACINAMIDE CRE TRIAMCIN Unapproved DrugNIACINAMIDE GEL SPIRONOL Unapproved DrugNIACINAMIDE GEL TRETINOI Unapproved DrugNIACINAMIDE GEL TRETINOI Unapproved DrugNIACINAMIDE OIN TACROLIM Unapproved DrugNICADAN TAB Vitamin/MineralNICAPRIN TAB Vitamin/MineralNICARD/NACL INJ 25/250ML Not properly listed with FDANICAZEL TAB Vitamin/MineralNICAZEL TAB FORTE Vitamin/MineralNICAZYME TAB Dietary SupplementNICOMIDE TAB Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
NICOMIDE TAB Vitamin/MineralNIMBEX INJ 10MG/ML LISTNIMBEX INJ 2MG/ML LISTNIMBEX INJ 2MG/ML LISTNITROGLYCER CAP 9MG ER Unapproved DrugNITRO-TIME CAP 2.5MG CR Unapproved DrugNITRO-TIME CAP 6.5MG CR Unapproved DrugNITRO-TIME CAP 9MG CR Unapproved DrugNIVA-FOL TAB Vitamin/MineralNIVA-PLUS TAB Vitamin/MineralNIVATOPIC CRE PLUS LISTNOCLOT-50 SOL ACD-A Not properly listed with FDANOPIOID-LMC MIS KIT LISTNOPIOID-TC MIS KIT LISTNOREPIN/NACL INJ 4/250ML Not properly listed with FDANOREPIN/NACL INJ 8/250ML Not properly listed with FDANORMAL SALIN INJ 0.9% Not properly listed with FDANORML SALINE INJ IV FLUSH Not properly listed with FDANORMLGEL AG GEL DeviceNOURILITE CRE Not properly listed with FDANOURISH LIQ Not properly listed with FDANOURIVAN CRE ANTIOX Not properly listed with FDANOVACORT GEL DESINOVOEIGHT INJ 1000UNIT Blood ComponentNOVOEIGHT INJ 1500UNIT Blood ComponentNOVOEIGHT INJ 2000UNIT Blood ComponentNOVOEIGHT INJ 250UNIT Blood ComponentNOVOEIGHT INJ 3000UNIT Blood ComponentNOVOEIGHT INJ 500UNIT Blood ComponentNOVOSEVEN RT INJ 1MG Blood ComponentNOVOSEVEN RT INJ 2MG Blood ComponentNOVOSEVEN RT INJ 5MG Blood ComponentNOVOSEVEN RT INJ 8MG Blood ComponentNOXIFINE EMU Surgical Supply/MedicalNOXIFOL-D TAB Not properly listed with FDANOXI-K CRE Not properly listed with FDANOXIPAK PAK Not properly listed with FDANP #2 DRUG CRE PREP KIT Not properly listed with FDANP THYROID TAB 120MG Unapproved DrugNP THYROID TAB 15MG Unapproved DrugNP THYROID TAB 30MG Unapproved DrugNP THYROID TAB 60MG Unapproved DrugNP THYROID TAB 90MG Unapproved DrugNUCARACLINPA KIT LISTNUCARARXPAK KIT LIST
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
NUDERMRXPAK PAK 120 LISTNUDERMRXPAK PAK 60 LISTNUDICLO PAK SOLUPAK LISTNUDICLO PAK TABPAK LISTNUDROXIPAK KIT DSDR-50 LISTNUDROXIPAK KIT DSDR-75 LISTNUDROXIPAK KIT E-400 LISTNUDROXIPAK KIT I-800 LISTNUDROXIPAK KIT M-15 LISTNUDROXIPAK KIT N-500 LISTNUDROXIPAK PAK LISTNUFOL TAB Vitamin/MineralNULEV TAB 0.125MG Unapproved DrugNUMBONEX LOT 2.75% Not properly listed with FDANUMOISYN LIQ Unapproved DrugNUMOISYN LOZ Unapproved DrugNUSURGEPAK KIT SURGICAL LISTNUTRASEB CRE Not properly listed with FDANUTRIARX KIT CREAMPAK LISTNUTRICAP TAB Vitamin/MineralNUTRIFAC ZX TAB Vitamin/MineralNUTRIVIT LIQ 800-15-1 Vitamin/MineralNUVAIL SOL 16% DeviceNUVAKAAN KIT 2.5-2.5% LISTNUVAKAAN II KIT LISTNUWIQ INJ 1000UNIT Blood ComponentNUWIQ INJ 2000UNIT Blood ComponentNUWIQ INJ 2500UNIT Blood ComponentNUWIQ INJ 250UNIT Blood ComponentNUWIQ INJ 3000UNIT Blood ComponentNUWIQ INJ 4000UNIT Blood ComponentNUWIQ INJ 500UNIT Blood ComponentNUWIQ KIT 1000UNIT Blood ComponentNUWIQ KIT 2000UNIT Blood ComponentNUWIQ KIT 2500UNIT Blood ComponentNUWIQ KIT 250UNIT Blood ComponentNUWIQ KIT 3000UNIT Blood ComponentNUWIQ KIT 4000UNIT Blood ComponentNUWIQ KIT 500UNIT Blood ComponentOAT GRAIN INJ EXTRACT Diagnostic AgentOB COMPLETE CAP ONE Vitamin/MineralOB COMPLETE CAP PETITE Vitamin/MineralOB COMPLETE TAB Vitamin/MineralOB COMPLETE TAB PREMIER Vitamin/MineralOB COMPLETE/ CAP DHA Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
OBIZUR INJ 500 UNIT Blood ComponentOBSTETRIX PAK DHA Vitamin/MineralOBSTETRIX EC TAB Vitamin/MineralOBSTETRX ONE CAP 38-1-225 Vitamin/MineralO-CAL TAB PRENATAL Vitamin/MineralO-CAL FA TAB Vitamin/MineralOCCLUVAN OIN Not properly listed with FDAOCTAPLAS INJ GROUP A Blood ComponentOCTAPLAS INJ GROUP AB Blood ComponentOCTAPLAS INJ GROUP B Blood ComponentOCTAPLAS INJ GROUP O Blood ComponentOCUVEL CAP 0.5MG Vitamin/MineralOLIVE TREE INJ 1:20 Non-standardized allergenicOMEGA-3 RX PAK COMPLETE LISTOMEGA-3/D-3 KIT WELLNESS LISTOMEPRAZOLE + SUS SYRSPEND Not properly listed with FDAOMNIBASE CRE Not properly listed with FDAOMNIFLEX DPR DeviceOMNIPAQUE INJ 140MG/ML Diagnostic AgentOMNIPAQUE INJ 180MG/ML Diagnostic AgentOMNIPAQUE INJ 240MG/ML Diagnostic AgentOMNIPAQUE INJ 300MG/ML Diagnostic AgentOMNIPAQUE INJ 350MG/ML Diagnostic AgentOMNIPAQUE SOL 12MG/ML Diagnostic AgentOMNIPAQUE SOL 9MG/ML Diagnostic AgentOMNISCAN INJ /NACL Diagnostic AgentOMNISCAN INJ 287MG/ML Diagnostic AgentOMNISCAN INJ 287MG/ML Diagnostic AgentOMNIVEX TAB Dietary SupplementONE VITE TAB 1MG PLUS Multi-vitamin w/ ironONEVITE TAB Vitamin/MineralONYCHO-MED KIT 250MG-2% Unapproved DrugOPIUM TIN 10MG/ML Unapproved DrugOPTIRAY 240 INJ 51% Diagnostic AgentOPTIRAY 300 INJ 64% Diagnostic AgentOPTIRAY 320 INJ 68% Diagnostic AgentOPTIRAY 350 INJ 74% Diagnostic AgentOPTISON INJ Diagnostic AgentORA-BLEND SUS Not properly listed with FDAORA-BLEND SF SUS Not properly listed with FDAORABLOC INJ 4%-1:100000 LISTORABLOC INJ 4%-1:200000 LISTORACIT SOL Unapproved DrugORAFATE PST 10% Not properly listed with FDAORAGENOMIC KIT MEDICATE Diagnostic Agent
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
ORANGE INJ EXTRACT Diagnostic AgentORAPEUTIC GEL Surgical Supply/MedicalORA-PLUS LIQ Not properly listed with FDAORA-SWEET SYP Not properly listed with FDAORA-SWEET SF SYP Not properly listed with FDAORCHARD GRAS INJ 100000BA Non-standardized allergenicORMECA KIT Not properly listed with FDAORTHO DF CAP 1-3775IU Dietary SupplementOSCIMIN SUB 0.125MG Unapproved DrugOSCIMIN TAB 0.125MG Unapproved DrugOSCIMIN TAB 0.125MG Unapproved DrugOSCIMIN SR TAB 0.375MG Unapproved DrugOTICIN HC DRO DESIOVACE PLUS AER 9.8% Unapproved DrugOVACE PLUS CRE 10% Unapproved DrugOVACE PLUS GEL 10% WASH Unapproved DrugOVACE PLUS LIQ 10% WASH Unapproved DrugOVACE PLUS LOT 9.8% Unapproved DrugOVACE PLUS SHA 10% Unapproved DrugOVACE WASH LIQ 10% Unapproved DrugOVEEZA CAP Multi-vitamin OVIDREL INJ Fertility AgentOXYTOCIN INJ 10UNT/ML LISTPAIN EASE AER MD STRM Not properly listed with FDAPAIN EASE AER MIST Not properly listed with FDAPAINGO KFT KIT LISTPANATUSS DXP LIQ Cough/ColdPANCURONIUM INJ 1MG/ML Not properly listed with FDAPANHEMATIN INJ 350MG Blood ComponentPAPAVERINE SOL 30MG/ML Unapproved DrugPAPAVERINE SOL PHENTOLA Erectile DysfunctionPAPAVER-PHEN SOL ALPROSTI Erectile DysfunctionPAPAVER-PHEN SOL ALRPOS Erectile DysfunctionPAREGORIC TIN 2MG/5ML Unapproved DrugPAREMYD SOL 1-0.25% Diagnostic AgentPB/BELLA ALK TAB 16.2MG Unapproved DrugPB/HYOSCY ELX ATR/SCOP Unapproved DrugPB/HYOSCY TAB ATR/SCOP Unapproved DrugP-CARE 100MX INJ 1%/0.5% LISTP-CARE D40 KIT 40MG/ML LISTP-CARE D40G KIT 40MG/ML LISTP-CARE D40MX KIT 40MG/ML LISTP-CARE D80 KIT 40MG/ML LISTP-CARE D80G KIT 40MG/ML LISTP-CARE D80MX KIT LIST
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
P-CARE K40 KIT 40MG/ML LISTP-CARE K40G KIT 40MG/ML LISTP-CARE K40MX KIT LISTP-CARE K80 KIT 40MG/ML LISTP-CARE K80G KIT 40MG/ML LISTP-CARE K80MX KIT LISTP-CARE M KIT 0.5% LISTP-CARE MG KIT 0.5% LISTP-CARE X KIT 1% LISTPCCA ALADERM CRE BASE Not properly listed with FDAPCCA COBASE OIN #1 Not properly listed with FDAPCCA COSMETI CRE HRT BASE Not properly listed with FDAPCCA CUSTOM CRE LIPO-MAX Not properly listed with FDAPCCA ELLAGE CRE VAGINAL Not properly listed with FDAPCCA LIPODER CRE BASE Not properly listed with FDAPCCA LIPOSOM CRE DRY Not properly listed with FDAPCCA LIPOSOM CRE NORMAL Not properly listed with FDAPCCA LIPOSOM CRE OILY Not properly listed with FDAPCCA LIPOSOM CRE SENSITIV Not properly listed with FDAPCCA MVC CRE BASE Not properly listed with FDAPCCA SWEET SYP -SF Not properly listed with FDAPCCA SYRUP SYP VEHICLE Not properly listed with FDAPCCA VANISH CRE BASE Not properly listed with FDAPCCA VANISHI CRE LIGHT Not properly listed with FDAPCCA VANPEN CRE BASE Not properly listed with FDAPCCA-PLUS SUS Not properly listed with FDAPCP 100 KIT LISTPE/GUAIFENES DRO 1.5-20MG Cough/ColdPEANUT INJ EXTRACT Diagnostic AgentPECAN NUT INJ EXTRACT Diagnostic AgentPECAN POLLEN SOL EXTRACT Non-standardized allergenicPEDIZOLPAK PAK 2%-2% Not properly listed with FDAPEG BASE OIN Not properly listed with FDAPENCREAM CRE Not properly listed with FDAPENDERM CRE Not properly listed with FDAPENICILLIUM INJ 1:20 Non-standardized allergenicPENICILLIUM INJ NOTATUM Non-standardized allergenicPENLEN EMU SPRAY DevicePENSOMAL CRE Not properly listed with FDAPENTAPHENE CRE Bulk IngredientPENTICAN PAK LISTPERCURA CAP Not properly listed with FDAPERENNIAL INJ RYE GRAS Non-standardized allergenicPERFORMAX CRE SALT SUP Not properly listed with FDAPETROLATUM OIN WHITE Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
PFIZER VACC INJ COVID-19 Unapproved DrugPH 12 STERIL SOL FLOLAN Not properly listed with FDAPH STRIPS TES PH 0-14 Diagnostic AgentPHARMABASE CRE COSMETIC Not properly listed with FDAPHARMABASE CRE HEAVY Not properly listed with FDAPHENACTIN AA LIQ PLUS Not properly listed with FDAPHENAZO TAB 200MG Unapproved DrugPHENAZOPYRID TAB 100MG Unapproved DrugPHENAZOPYRID TAB 200MG Unapproved DrugPHENDIMETRAZ CAP 105MG ER Anorexic, Anti-obesity AgentPHENDIMETRAZ TAB 35MG Anorexic, Anti-obesity AgentPHENO/BELLA ELX ALKALOID Unapproved DrugPHENOHYTRO ELX Unapproved DrugPHENOHYTRO TAB Unapproved DrugPHENOL INJ 6% Not properly listed with FDAPHENTERMINE CAP 15MG Anorexic, Anti-obesity AgentPHENTERMINE CAP 30MG Anorexic, Anti-obesity AgentPHENTERMINE CAP 37.5MG Anorexic, Anti-obesity AgentPHENTERMINE TAB 37.5MG Anorexic, Anti-obesity AgentPHENYLEP HCL INJ 0.8/10ML Unapproved DrugPHENYLEP HCL INJ 1MG/10ML Unapproved DrugPHENYLEPHRIN INJ 0.4/10ML Unapproved DrugPHENYLEPHRIN INJ 0.5/5ML Not properly listed with FDAPHENYLEPHRIN INJ 1MG/1ML Erectile DysfunctionPHEODOYO CRE Not properly listed with FDAPHEXXI GEL ContraceptivesPHEYO CRE Not properly listed with FDAPHLAG SPR Not properly listed with FDAPHOMA EXTRAC INJ 20000PNU Non-standardized allergenicPHOSPHA 250 TAB NEUTRAL Unapproved DrugPHOSPHASAL TAB Unapproved DrugPHOSPHOROUS TAB Not properly listed with FDAPHOSPHO-TRIN TAB 250 NEUT Medical FoodPHYS EZ USE KIT M-PRED LISTPHYTOBASE CRE Bulk IngredientPHYTONADIONE INJ 10MG/ML Vitamin/MineralPHYTONADIONE INJ 1MG/0.5 Vitamin/MineralPHYTONADIONE TAB 5MG Vitamin/MineralPICO WOUND KIT THER SYS Not properly listed with FDAPISTACHIO INJ EXTRACT Diagnostic AgentPITOCIN INJ 10UNT/ML LISTPKU EASY TAB Not properly listed with FDAPKU EASY TAB MICROTAB Not properly listed with FDAPLACEBO #00 CAP Unapproved DrugPLASBUMIN-25 INJ 25% Blood Component
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
PLASBUMIN-5 INJ 5% Blood ComponentPLEGISOL SOL Not properly listed with FDAPLEXION CRE 9.8-4.8% Unapproved DrugPLEXION LIQ 9.8-4.8% Unapproved DrugPLEXION LOT 9.8-4.8% Unapproved DrugPLEXION CLTH PAD 9.8-4.8% Unapproved DrugPLIAGLIS KIT 7-7% LISTPLO GEL MEDIFLO Not properly listed with FDAPLO MEDIFLO KIT KIT Not properly listed with FDAPLO TRANSDER CRE Not properly listed with FDAPLO20 GEL FLOWABLE Not properly listed with FDAPLO20 BASE GEL Not properly listed with FDAPNEUMOVAX 23 INJ 25/0.5 Pneumococcal VaccinePNV OB+DHA PAK Vitamin/MineralPNV TABS TAB 29-1MG Vitamin/MineralPNV-DHA CAP Vitamin/MineralPNV-DHA CAP DOCUSATE Vitamin/MineralPNV-OMEGA CAP Vitamin/MineralPNV-SELECT TAB Vitamin/MineralPOD-CARE 100 KIT 30MG/5ML Not properly listed with FDAPOD-CARE 100 KIT 40MG/ML Not properly listed with FDAPOD-CARE 100 KIT 40MG/ML Not properly listed with FDAPOD-CARE 100 KIT CMX Not properly listed with FDAPOD-CARE 100 KIT KMX Not properly listed with FDAPOD-CARE100C INJ 30MG/5ML Not properly listed with FDAPODIAPN CAP Vitamin/MineralPODOCON SOL 25% Unapproved DrugPOINT OF KIT CARE KM LISTPOINT OF KIT CARE L.2 LISTPOINT OF KIT CARE L.5 LISTPOINT OF CAR KIT LM DEP 2 LISTPOINT OF CAR KIT LM-2.2 LISTPOINT OF CAR KIT LM-2.5 LISTPOLIBAR PLUS SUS 105% Diagnostic AgentPOLYOX LAURY INJ 5% Not properly listed with FDAPOLYPEG OIN BASE Not properly listed with FDAPOLY-PREP KIT LISTPOLY-VI-FLOR CHW 0.25MG Vitamin/MineralPOLY-VI-FLOR CHW 0.5MG Vitamin/MineralPOLY-VI-FLOR CHW 1MG Vitamin/MineralPOLY-VI-FLOR CHW W/IRON Vitamin/MineralPOLY-VI-FLOR MIS FS Vitamin/MineralPOLY-VI-FLOR MIS FS 0.25 Vitamin/MineralPOLY-VI-FLOR MIS FS 0.5MG Vitamin/MineralPOLY-VI-FLOR SUS /IRON Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
POLY-VI-FLOR SUS 0.25/ML Vitamin/MineralPORK EXTRACT INJ 1:10 Diagnostic AgentPORT-PREP KIT 2.5-2.5% Not properly listed with FDAPOT CHLORIDE TAB 25MEQ EF Unapproved DrugPOT CITRATE- PAK CIT ACID Unapproved DrugPOT HYDROXID SOL 5% Unapproved DrugPOTABA CAP 500MG DESIPR BENZOYL LIQ 7% WASH Unapproved DrugPR CREAM KIT Unapproved DrugPR NATAL 400 PAK Vitamin/MineralPR NATAL 400 PAK EC Vitamin/MineralPR NATAL 430 PAK Vitamin/MineralPR NATAL 430 PAK EC Vitamin/MineralPRACASIL TM- CRE PLUS Not properly listed with FDAPRALIDOXIME INJ 600/2ML Not properly listed with FDAPRAMOSONE CRE 1-1% LISTPRAMOSONE CRE 1-2.5% DESIPRAMOSONE LOT 1% LISTPRAMOSONE LOT 2.5% LISTPRAMOSONE OIN 1% DESIPRAMOSONE OIN 2.5% DESIPRAMOSONE E CRE 1-2.5% DESIPRAMOTIC DRO 1-0.1% Unapproved DrugPRAMOX GEL 1% Not properly listed with FDAPRASTERA KIT Unapproved DrugPRE & POST MIS SX POUCH LISTPRED-GAT-BRO INJ Unapproved DrugPRED-GATI SUS 1-0.5% Unapproved DrugPRED-GATIFL- SUS BROMFENA Unapproved DrugPREDN GATI SOL 1-0.5% Unapproved DrugPREDNIS/BROM SUS 1-0.075% Unapproved DrugPRE-FOLIC TAB 1-100MG Vitamin/MineralPREGENNA TAB Vitamin/MineralPREMESISRX TAB Vitamin/MineralPRENA 1 TRUE MIS Vitamin/MineralPRENA1 CHW Vitamin/MineralPRENA1 PEARL CAP Vitamin/MineralPRENAISSANCE CAP Vitamin/MineralPRENAISSANCE CAP PLUS Vitamin/MineralPRENARA CAP PRENATAL Vitamin/MineralPRENATABS RX TAB Vitamin/MineralPRENATAL TAB 27-1MG Vitamin/MineralPRENATAL 19 CHW 29-1MG Vitamin/MineralPRENATAL 19 CHW TAB Vitamin/MineralPRENATAL 19 TAB 29-1MG Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
PRENATAL DHA PAK 27-1-250 Vitamin/MineralPRENATAL VIT TAB LOW IRON Vitamin/MineralPRENATAL+FE TAB 29-1MG Vitamin/MineralPRENATAL-U CAP 106.5-1 Vitamin/MineralPRENATE CAP ENHANCE Vitamin/MineralPRENATE CAP ESSENT Vitamin/MineralPRENATE CAP ESSENTIA Vitamin/MineralPRENATE CAP PIXIE Vitamin/MineralPRENATE CAP RESTORE Vitamin/MineralPRENATE CHW 0.6-0.4 Vitamin/MineralPRENATE TAB ELITE Vitamin/MineralPRENATE TAB ELITE Vitamin/MineralPRENATE AM TAB 1MG Vitamin/MineralPRENATE DHA CAP Vitamin/MineralPRENATE DHA CAP Vitamin/MineralPRENATE MINI CAP Vitamin/MineralPRENATE MINI CAP Vitamin/MineralPRENATRIX TAB Vitamin/MineralPRENATRYL TAB Multi-vitamin w/ ironPRENATVITE TAB COMPLETE Vitamin/MineralPRENATVITE TAB PLUS Vitamin/MineralPRENATVITE TAB RX Vitamin/MineralPRENIS-BROMF SOL 1-0.075% Unapproved DrugPRE-PEN INJ Diagnostic AgentPREPIV SUPPL KIT Not properly listed with FDAPREPLUS TAB 27-1MG Vitamin/MineralPRESERA AER Not properly listed with FDAPRETAB TAB 29-1MG Vitamin/MineralPREVDNT 5000 PST 1.1% Unapproved DrugPREVDNT 5000 PST 1.1-5% Unapproved DrugPREVIDENT CRE 5000 PLS Unapproved DrugPREVIDENT GEL 1.1% Unapproved DrugPREVIDENT GEL 1.1% BER Unapproved DrugPREVIDENT GEL 1.1% MIN Unapproved DrugPREVIDENT PST 1.1% Not properly listed with FDAPREVIDENT SOL 0.2% Unapproved DrugPREVIDOLRX PAK ANALGESI LISTPREVIDOLRX PAK PLUS LISTPREVNAR 13 INJ Pneumococcal VaccinePRIKAAN KIT 2.5-2.5% LISTPRIKAAN LITE KIT 2.5-2.5% LISTPRILO PATCH KIT LISTPRILO PATCH KIT II LISTPRILOLID KIT 2.5-2.5% LISTPRILOPENTIN MIS LIST
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
PRILOVIX KIT 2.5-2.5% Unapproved DrugPRILOVIX LIT KIT 2.5-2.5% Unapproved DrugPRILOVIXIL KIT Unapproved DrugPRILOXX LP KIT 2.5-2.5% Not properly listed with FDAPRIMACARE CAP Vitamin/MineralPRIVET EXT INJ 1:20 Non-standardized allergenicPRIZOPAK II KIT 2.5-2.5% LISTPRIZOTRAL KIT LISTPRIZOTRAL II KIT LISTPRO DNA KIT KIT Diagnostic AgentPROBICHEW CHW Dietary Supplement PRO-C-DURE 5 KIT 40MG/ML LISTPRO-C-DURE 6 KIT 40MG/ML LISTPROCORT CRE Unapproved DrugPRO-CRITIC POW Not properly listed with FDAPROCTOCORT SUP 30MG DESIPROCTOFOAM AER HC 1% Unapproved DrugPRODIGEN CAP Dietary SupplementPRODRIN TAB DESIPRODRIN TAB DESIPROFILNINE INJ 1000UNIT Blood ComponentPROFILNINE INJ 1500UNIT Blood ComponentPROFILNINE INJ 500UNIT Blood ComponentPROGESTERONE CRE Not properly listed with FDAPROGESTERONE CRE 10% KIT Bulk IngredientPROGESTERONE SUP VGS 100 Not properly listed with FDAPROGESTERONE SUP VGS 200 Not properly listed with FDAPROHANCE INJ 279.3/ML Diagnostic AgentPROLEEVA CAP Not properly listed with FDAPROLEVA TAB Not properly listed with FDAPROMACTIN AA SUS PLUS Not properly listed with FDAPROMELLA CAP PREBIOTI Dietary Supplement PROMETH/COD SOL 6.25-10 Cough/ColdPROMETH/COD SYP 6.25-10 Cough/ColdPROMETH/PE/ SYP CODEINE Cough/ColdPROMETHAZINE SOL DM Cough/ColdPROMETHAZINE SYP DM Cough/ColdPROMISEB CRE Unapproved DrugPROMISEB KIT COMPLETE Unapproved DrugPROPECIA TAB 1MG CosmeticPROPOFOL INJ General AnestheticPROPOFOL INJ 100/10ML General AnestheticPROPOFOL INJ 1000MG General AnestheticPROPOFOL INJ 150/15 General AnestheticPROPOFOL INJ 200/20ML General Anesthetic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
PROPOFOL INJ 500/50ML General AnestheticPROPOFOL INJ 50MG/5ML General AnestheticPROPOVEN EMU 2% General anestheticPROPOVEN INJ General AnestheticPROPOVEN INJ 200/20ML General AnestheticPROPOVEN INJ 500/50ML General AnestheticPROSILK GEL DevicePROSTIN VR INJ 500MCG Not properly listed with FDAPROTEOLIN TAB Not properly listed with FDAPROTEXA CRE 42% Unapproved DrugPROTHELIAL PST 10% Not properly listed with FDAPROTYL AG GEL DevicePROVAD CAP Dietary SupplementPROVENGE INJ LISTPROVIDA DHA CAP Vitamin/MineralPROVIDA OB CAP Vitamin/MineralPROVISC INJ 1% DevicePROVOCHOLINE SOL 100MG Diagnostic AgentPRUCLAIR CRE LISTPRUMYX CRE LISTPRUTECT EMU Surgical Supply/MedicalP-SILOXAN DS CRE Not properly listed with FDAPSORIZIDE TAB FORTE Unapproved DrugPSORIZIDE TAB ULTRA Unapproved DrugPUDEND/LOCAL KIT 1% LIDO Not properly listed with FDAPULMONA CAP Medical FoodPULMOSAL NEB 7% DevicePUREFE OB CAP PLUS Vitamin/MineralPUREFOLIX TAB 1-5000 Unapproved DrugPURIFIED LIQ WATER OTC ProductPYRIDIUM TAB 100MG Unapproved DrugPYRIDIUM TAB 200MG Unapproved DrugPYRIDOXAL-5- INJ PHOSPHAT Vitamin/MineralPYRIDOXINE INJ 100MG/ML Vitamin/MineralPYROPHOSPHAT KIT 99M Diagnostic AgentQBREXZA PAD 2.4% LISTQSYMIA CAP 11.25-69 Anorexic, Anti-obesity AgentQSYMIA CAP 15-92MG Anorexic, Anti-obesity AgentQSYMIA CAP 3.75-23 Anorexic, Anti-obesity AgentQSYMIA CAP 7.5-46MG Anorexic, Anti-obesity AgentQUAD-MIX INJ Erectile DysfunctionQUEEN PALM SOL EXTRACT Non-standardized allergenicQUELICIN INJ 20MG/ML LISTQUFLORA CHW Vitamin/MineralQUFLORA FE CHW Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
QUFLORA FE DRO 0.25-9.5 Vitamin/MineralQUFLORA PED CHW 0.25MG Vitamin/MineralQUFLORA PED CHW 0.5MG Vitamin/MineralQUFLORA PED CHW 1MG Vitamin/MineralQUFLORA PED DRO 0.25MG Vitamin/MineralQUFLORA PED DRO 0.5MG/ML Vitamin/MineralQUICKVUE KIT STREP A Diagnostic AgentQUICKVUE + KIT STREP A Diagnostic AgentQUICKVUE A+B KIT INFLUENZ Diagnostic AgentQUICKVUE INL KIT STREP A Diagnostic AgentQUINIXIL PAK 0.1%-5% LISTQUINJA GEL 1.25-1% Unapproved DrugRABBIT INJ EPITHELI Non-standardized allergenicRABBIT EPITH INJ 1:20 Non-standardized allergenicRADIAGEL GEL Not properly listed with FDARADIAPLEXRX GEL Not properly listed with FDARAPID GEL RX GEL Unapproved DrugRAPPORT RLS KIT Erectile DysfunctionRAPPORT VTD KIT Erectile DysfunctionRASPBERRY SYP Bulk IngredientREA LO 39 CRE 39% Unapproved DrugREADI-CAT 2 SUS Diagnostic AgentREADI-CAT 2 SUS BANANA Diagnostic AgentREADI-CAT 2 SUS BERRY Diagnostic AgentREADI-CAT 2 SUS MOCHACCI Diagnostic AgentREADI-CAT 2 SUS VANILLA Diagnostic AgentREADY BETAME KIT 30MG/5ML LISTREADY DEXAME KIT 10MG/ML LISTREADY KETORO KIT 15MG/ML LISTREADY LIDOCA KIT 1% LISTREADYSHARP + KIT BETAMETH LISTREADYSHARP + KIT DEXAMETH LISTREADYSHARP + KIT KETOROLA LISTREADYSHARP + KIT METHYLPR LISTREADYSHARP-A KIT 1%/0.5% LISTREADYSHARP-K KIT LISTREBINYN SOL 1000UNIT Blood ComponentREBINYN SOL 2000UNIT Blood ComponentREBINYN SOL 500UNIT Blood ComponentRECEDO GEL Not properly listed with FDARECOMBINATE INJ Blood ComponentRECOMBINATE INJ Blood ComponentRECOMBINATE INJ 220-400 Blood ComponentRECOMBINATE INJ 401-800 Blood ComponentRECOMBINATE INJ 801-1240 Blood Component
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
RED BIRCH SOL EXTRACT Non-standardized allergenicRED CEDAR SOL EXTRACT Non-standardized allergenicRED MAPLE INJ 1:20 Non-standardized allergenicRED MULBERRY INJ 1:20 Non-standardized allergenicRED TOP GRAS INJ 100000BA Non-standardized allergenicREDICHEW RX CHW Vitamin/MineralREFISSA CRE 0.05% CosmeticREGENECARE GEL OTC ProductREGIMEX TAB 25MG Anorexic, Anti-obesity AgentREGIOCIT SOL Unapproved DrugREJUVACARE CRE PLUS Not properly listed with FDARELADOR PAK KIT 2.5-2.5% LISTRELADOR PAK KIT PLUS LISTRELAGARD GEL Unapproved DrugRELNATE DHA CAP Vitamin/MineralREMEDIENT CAP Vitamin/MineralREMERGENT HQ CRE 4% CosmeticREMIGEN CREA CRE Not properly listed with FDARENAL CAP Vitamin/MineralRENATABS MIS IRON Vitamin/MineralRENATABS TAB Vitamin/MineralRENO CAP Vitamin/MineralRENOVA CRE 0.02% CosmeticRENOVA PUMP CRE 0.02% CosmeticRENOVO PAD 0.0375-5 Unapproved DrugREQ 49+ TAB Vitamin/MineralRESECTISOL SOL 5% Diagnostic AgentRESERVAPAK SYP Not properly listed with FDARESERVAPAK SYP PLUS Not properly listed with FDARESET MIS IOS APP Not properly listed with FDARESET APP MIS ANDROID Not properly listed with FDARESET APP MIS IOS/ANDR Not properly listed with FDARESET-O MIS IOS APP Not properly listed with FDARESET-O MIS IOS/ANDR Not properly listed with FDARESET-O APP MIS ANDROID Not properly listed with FDARESTORA RX CAP 60-1.25 Not properly listed with FDARESTORA SPRI PAK 15-0.25 LISTRESTORE SILV PAD 2"X2" Not properly listed with FDARESTORE SILV PAD 4"X4" Not properly listed with FDARESTORE SILV PAD 4"X4.75" Not properly listed with FDARESTORE SILV PAD 4"X5" Not properly listed with FDARESTORE SILV PAD 6"X8" Not properly listed with FDAREVESTA CAP 1MG-5750 Not properly listed with FDAREXASIL KIT Not properly listed with FDAREZESOL LOT 2-6% Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
R-GENE 10 INJ 10% Diagnostic AgentRGH PIGWEED SOL EXTRACT Non-standardized allergenicRHEOSPRAY LIQ Not properly listed with FDARHEUMATE CAP Medical FoodRHIZOPUS INJ 1:10 Non-standardized allergenicRIASTAP SOL 1GM Blood ComponentRIAX AER 5.5% OTC ProductRIAX AER 9.5% OTC ProductRIBOZEL CAP Not properly listed with FDARICE EXTRACT INJ 1:10 Diagnostic AgentRIFAMPIN SUS 25MG/ML Not properly listed with FDARIXUBIS INJ 1000UNIT Blood ComponentRIXUBIS INJ 2000UNIT Blood ComponentRIXUBIS INJ 250 UNIT Blood ComponentRIXUBIS INJ 3000UNIT Blood ComponentRIXUBIS INJ 500UNIT Blood ComponentR-NATAL OB CAP 20-1-320 Vitamin/MineralROCURON BROM INJ 50MG/5ML Not properly listed with FDAROCURONIUM INJ 100/10ML LISTROCURONIUM INJ 100MG/10 LISTROCURONIUM INJ 10MG/ML LISTROCURONIUM INJ 10MG/ML LISTROCURONIUM INJ 50MG/5ML LISTROP-CLON-KET INJ 15/50ML Not properly listed with FDAROPIDEX KIT Unapproved DrugROPIVAC/NACL INJ 0.2-0.9% Not properly listed with FDAROPIVAC/NACL INJ 2MG/ML Not properly listed with FDAROPIVACAINE INJ Unapproved DrugROPIVACAINE INJ 0.2-0.9% Not properly listed with FDAROSADAN KIT 0.75% LISTROSADAN KIT 0.75% LISTROSANIL EMU CLEANSER Unapproved DrugROSE GLO TES 1.5MG Diagnostic AgentROXIFOL-D TAB 1-500 Not properly listed with FDARRB PAK LISTRUSS THISTLE SOL EXTRACT Non-standardized allergenicRX-SPECIMEN KIT COLLECTI Diagnostic AgentRYNODERM CRE 37.5% Not properly listed with FDASA3 DERM CRE Not properly listed with FDASACCHARIN POW SODIUM Bulk IngredientSACCHAROMYCE INJ 1:20 Diagnostic AgentSACCHAROMYCE INJ CEREVISI Non-standardized allergenicSAGEBRUSH SOL EXTRACT Non-standardized allergenicSALEX SHA 6% Unapproved DrugSALEX CREAM KIT 6% Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SALEX LOTION KIT 6% Unapproved DrugSALICYLIC AER 6% Unapproved DrugSALICYLIC SUS SULFACET Unapproved DrugSALICYLIC SUS SULFACET Unapproved DrugSALICYLIC AC CRE 6% Unapproved DrugSALICYLIC AC GEL 6% Unapproved DrugSALICYLIC AC KIT 6% Unapproved DrugSALICYLIC AC KIT 6% CREAM Unapproved DrugSALICYLIC AC KIT 6% LOTN Unapproved DrugSALICYLIC AC LIQ 27.5% Unapproved DrugSALICYLIC AC LOT 6% Unapproved DrugSALICYLIC AC SHA 6% Unapproved DrugSALICYLIC AC SOL 26% Unapproved DrugSALICYLIC AC SOL 28.5% ER Unapproved DrugSALIMEZ CRE 6% Not properly listed with FDASALIMEZ FORT CRE 10% Not properly listed with FDASALINE FLUSH INJ 0.9% Not properly listed with FDASALINE FLUSH INJ ZR 0.9% Not properly listed with FDASALINE/PHENO SOL LISTSALISOL SOL 23% Not properly listed with FDASALISOL FORT SOL 26% Not properly listed with FDASALITECH LOT 5% Not properly listed with FDASALITECH LOT FORTE Not properly listed with FDASALIVAMAX POW LISTSALRIX SUS 50% Not properly listed with FDASALSALATE TAB 500MG Unapproved DrugSALSALATE TAB 750MG Unapproved DrugSALT DURABLE CRE Not properly listed with FDASALT STABLE CRE LS ADV Not properly listed with FDASALTSTABLE CRE Not properly listed with FDASALVAX AER 6% Unapproved DrugSALVAX DUO KIT PLUS Unapproved DrugSANADERMRX KIT SKIN REP LISTSANARE CRE ADVANCED Not properly listed with FDASANARE SCAR CRE THERAPY Not properly listed with FDASASH KIT 100/ML Not properly listed with FDASAXENDA INJ 18MG/3ML Anorexic, Anti-obesity AgentSCAR MANAGE GEL Not properly listed with FDASCAR PATCH PAD PREMIUM Unapproved DrugSCARCARE KIT LARGE Not properly listed with FDASCARCIN GEL DeviceSCARCIN LIQ ROLL-ON DeviceSCARSILK GEL DeviceSCARZEN SKIN KIT REPAIR LISTSCLEROSOL AER INTRAPLE LIST
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SEBUDERM GEL Not properly listed with FDASECREFLO INJ 16MCG Diagnostic AgentSEDANARE CRE Not properly listed with FDASELECT-OB CHW Vitamin/MineralSELECT-OB CHW Vitamin/MineralSELECT-OB+ PAK DHA Vitamin/MineralSELENIUM SUL SHA 2.25% Unapproved DrugSELENIUM SUL SHA 2.3% Unapproved DrugSELRX SHA 2.3% Unapproved DrugSE-NATAL 19 CHW Vitamin/MineralSE-NATAL 19 TAB Vitamin/MineralSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE INJ -MPF/EPI LISTSENSORCAINE/ INJ EPI 0.25 LISTSENSORCAINE/ INJ EPI 0.5% LISTSENTRA AM CAP Medical FoodSENTRA PM CAP Medical FoodSERAQUA LIQ Not properly listed with FDASERMORELIN INJ 15MG Diagnostic AgentSERMORELIN INJ 6MG Diagnostic AgentSERMORELIN INJ 9MG Diagnostic AgentSESAME SEED INJ EXTRACT Diagnostic AgentSESTAMIBI KIT TC99M Diagnostic AgentSEVENFACT INJ 1MG Blood ComponentSEVENFACT INJ 5MG Blood ComponentSEVOFLURANE SOL General AnestheticSF GEL 1.1% Unapproved DrugSF 5000 PLUS CRE 1.1% Unapproved DrugSHAGBARK HCK SOL EXTRACT Non-standardized allergenicSHEEP SORREL INJ 1:20 Non-standardized allergenicSHELLGEL SOL DeviceSHORT RAGWEE INJ 1:20 Non-standardized allergenicSHRIMP INJ EXTRACT Diagnostic AgentSIDEROL TAB Vitamin/MineralSILA III PAK LISTSILALITE PAK MIS LISTSILDENAFIL TAB 100MG Sexual Dysfunction AgentSILDENAFIL TAB 25MG Sexual Dysfunction AgentSILDENAFIL TAB 50MG Sexual Dysfunction AgentSILIPAC KIT DeviceSIL-K PAD MIS LARGE Not properly listed with FDASIL-K PAD MIS MEDIUM Not properly listed with FDASIL-K PAD MIS SMALL Not properly listed with FDASILOSOME CRE TRANSDER Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SILPROTEX CRE PLUS Not properly listed with FDASILVASORB GEL Not properly listed with FDASILVER NITRA SOL 0.5% Unapproved DrugSILVER NITRA SOL 10% Unapproved DrugSILVER NITRA SOL 25% Unapproved DrugSILVER NITRA SOL 50% Unapproved DrugSILVRSTAT GEL DRESSING Surgical Supply/MedicalSIMPLE SYP Bulk IngredientSINOGRAFIN INJ Diagnostic AgentSITZMARKS CAP Diagnostic AgentSITZMARKS CAP COMBO PACKAGE Diagnostic AgentSKIN BLEACH CRE 4% CosmeticSKIN BLEACH CRE SUNSCREE CosmeticSKYADERM-LP KIT Unapproved DrugSKYY DERM CRE Not properly listed with FDASOD BICARB SOL D5W Unapproved DrugSOD CHLORIDE INJ 0.9% LISTSOD CHLORIDE INJ 0.9% LISTSOD CHLORIDE INJ 0.9%BACT LISTSOD CHLORIDE INJ 23.4% LISTSOD CHLORIDE INJ 4MEQ/ML LISTSOD CHLORIDE NEB 0.9% Not properly listed with FDASOD CIT-GENT INJ 4%-320 Unapproved DrugSOD CITRATE SOL CITR ACD Unapproved DrugSOD FLUORIDE CHW 0.25MG F Unapproved DrugSOD FLUORIDE CHW 0.5MG F Unapproved DrugSOD FLUORIDE CHW 1.1MG Unapproved DrugSOD FLUORIDE CHW 1MG F Unapproved DrugSOD FLUORIDE CHW 2.2MG Unapproved DrugSOD FLUORIDE DRO 0.5MG/ML Unapproved DrugSOD FLUORIDE PST 1.1% Unapproved DrugSOD FLUORIDE PST 1.1% Unapproved DrugSOD FLUORIDE PST 1.1-5% Unapproved DrugSOD FLUORIDE TAB 0.5MG F Unapproved DrugSOD FLUORIDE TAB 1MG F Unapproved DrugSOD NITRITE INJ 30MG/ML LISTSOD SACCHARI GRA Not properly listed with FDASOD SUL/SULF CRE 10-2% Unapproved DrugSOD SUL/SULF CRE 10-5% Unapproved DrugSOD SUL/SULF CRE 9.8-4.8% Unapproved DrugSOD SUL/SULF EMU 10-5% Unapproved DrugSOD SUL/SULF EMU 10-5% Unapproved DrugSOD SUL/SULF KIT Unapproved DrugSOD SUL/SULF LIQ 10-2% Unapproved DrugSOD SUL/SULF LIQ 9.8-4.8% Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SOD SUL/SULF LIQ 9-4.5% Unapproved DrugSOD SUL/SULF LIQ WASH Unapproved DrugSOD SUL/SULF LOT 10-5% Unapproved DrugSOD SUL/SULF LOT 9.8-4.8% Unapproved DrugSOD SUL/SULF PAD 10-4% Unapproved DrugSOD SUL/SULF SUS 10-5% Unapproved DrugSOD SUL/SULF SUS 8-4% Unapproved DrugSOD SULF/SUL EMU 10-5% Unapproved DrugSOD SULFACET GEL 10% Unapproved DrugSOD SULFACET SHA 10% Unapproved DrugSOD THIOSULF INJ 25% Unapproved DrugSODIUM POW BICARBON Bulk IngredientSODIUM BICAR SOL 8.4% Not properly listed with FDASODIUM CHLOR NEB 10% Unapproved DrugSODIUM CHLOR NEB 3% Unapproved DrugSODIUM CHLOR NEB 7% Unapproved DrugSODIUM CITRA SOL 4% Not properly listed with FDASODIUM FLUOR CRE 1.1 Unapproved DrugSODIUM FLUOR CRE 5000 PLS Unapproved DrugSODIUM FLUOR CRE 5000 PPM Unapproved DrugSODIUM FLUOR GEL 1.1% Unapproved DrugSODIUM SULFA LIQ 10% WASH Unapproved DrugSOFIA KIT STREP A Diagnostic AgentSOFIA KIT STREP A+ Diagnostic AgentSOFIA 2 SARS KIT ANTIGEN Diagnostic AgentSOFIA A+B KIT INFLUENZ Diagnostic AgentSOFIA SARS KIT ANTIGEN Diagnostic AgentSOFIA2 FLU/ KIT SARS FIA Diagnostic AgentSOLARAVIX PAK 3% Unapproved DrugSOLOX GEL DeviceSOLULINE KIT 2.5-2.5% Not properly listed with FDASOLUPAK PAK Not properly listed with FDASOLUPICC KIT 2.5-2.5% Not properly listed with FDASOLU-PREF KIT Not properly listed with FDASOLVATECH SUS PLUS Not properly listed with FDASOLVATECH SYP SWEET SF Not properly listed with FDASOLYDRA LIQ Not properly listed with FDASOMRYST MIS LISTSONAFINE EMU Surgical Supply/MedicalSOOTHEE PAD Unapproved DrugSORBITOL SOL 3% IRR LISTSORBITOL SOL 3.3% IRR LISTSORBITOL-MAN SOL LISTSORREL/DOCK INJ EXTRACT Non-standardized allergenicSOYBEAN INJ EXTRACT Diagnostic Agent
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SPASCUPREEL INJ Unapproved DrugSPECIMEN KIT COLLECTI Diagnostic AgentSPECTRAGEL GEL Not properly listed with FDASPEEDGEL RX GEL Unapproved DrugSPHERUSOL INJ Diagnostic AgentSPINAL/EPIDU KIT CL CATH Not properly listed with FDASPINAL/EPIDU KIT OPN CATH Not properly listed with FDASPINY SOL PIGWEED Non-standardized allergenicSSKI SOL 1GM/ML Vitamin/MineralSSS CRE 10%-5% Unapproved DrugSSS 10-5 AER 10-5% Unapproved DrugSTANDARDIZED SOL MITE Non-standardized allergenicSTANDARDIZED SOL MITE MIX LISTSTAXYN TAB 10MG Erectile DysfunctionSTEMPHYLIUM SOL 20000PNU Non-standardized allergenicSTENDRA TAB 100MG Erectile DysfunctionSTENDRA TAB 200MG Erectile DysfunctionSTENDRA TAB 50MG Erectile DysfunctionSTERA BASE CRE Not properly listed with FDASTERIL TALC SUS 5GM LISTSTERIL WATER INJ LISTSTERIL WATER INJ LISTSTERILE INJ WATER Not properly listed with FDASTERILE DILU SOL EPOPROS LISTSTERILE DILU SOL FLOLAN LISTSTERILE DILU SOL TREPROST LISTSTRATA CTX GEL DeviceSTRATA GRT GEL DeviceSTRATA MARK GEL DeviceSTRATA TRIZ GEL DeviceSTRATA XRT GEL DeviceSTRAWBERRY INJ EXTRACT Diagnostic AgentSTROVITE FOR SYP Vitamin/MineralSTROVITE FOR TAB Vitamin/MineralSTROVITE ONE TAB Vitamin/MineralSUCCINYL CHO INJ 100/5ML Not properly listed with FDASUCCINYL CHO INJ 140/7ML Not properly listed with FDASUCCINYL CHO INJ 200/10ML Not properly listed with FDASUCCINYLCHOL INJ 100/5ML Not properly listed with FDASUCCINYLCHOL INJ 140/7ML Not properly listed with FDASUCCINYLCHOL INJ 200/10ML Not properly listed with FDASUCCINYLCHOL INJ 20MG/ML Not properly listed with FDASUFENTANIL INJ 100/2ML General AnestheticSUFENTANIL INJ 250/5ML General AnestheticSUFENTANIL INJ 50MCG/ML General Anesthetic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SUL SOD/SULF PAD 10-4% Unapproved DrugSULF/SUNSCRN KIT 9-4.5% Unapproved DrugSULFACLEANSE SUS 8-4% Unapproved DrugSULFAMEZ EMU 10-1% Not properly listed with FDASULFUR COLLO KIT 99M Diagnostic AgentSULFUR/RESOR LOT 5-2% Not properly listed with FDASUMADAN KIT Unapproved DrugSUMADAN WASH LIQ 9-4.5% Unapproved DrugSUMADAN XLT KIT 9-4.5% Unapproved DrugSUMAXIN PAD 10-4% Unapproved DrugSUMAXIN CP KIT Unapproved DrugSUMAXIN WASH LIQ 9-4% Unapproved DrugSUPER INJ QUAD-MIX Erectile DysfunctionSUPER INJ TRI-MIX Erectile DysfunctionSUPER BI-MIX INJ 150-10MG Erectile DysfunctionSUPERVITE LIQ Vitamin/MineralSUPPORT LIQ Vitamin/MineralSUPPORT-500 CAP Vitamin/MineralSUPRANE INH General AnestheticSUPRANE SOL General AnestheticSUPREME CRE Not properly listed with FDASURE RESULT KIT O3D3 SYS LISTSURE RESULT MIS DSS PACK LISTSUSPENDRX SUS SWEET Not properly listed with FDASUSPENDRX SUS UNSWEET Not properly listed with FDASUSPENSION SUS VEHICLE Not properly listed with FDASUVICORT EMU DeviceSWABFLUSH INJ 0.9% Not properly listed with FDASWEET CORN INJ EXTRACT Diagnostic AgentSWEET GUM INJ 1:20 Non-standardized allergenicSWEET VERNAL INJ GRASS PO Non-standardized allergenicSX1 POST-OP KIT MEDICATE LISTSYMAX DUOTAB TAB Unapproved DrugSYMAX-SL SUB 0.125MG Unapproved DrugSYMAX-SR TAB 0.375MG Unapproved DrugSYNAGEX CAP 1.25MG Vitamin/MineralSYNALAR KIT 0.025% LISTSYNALAR KIT 0.025% LISTSYNALAR TS KIT 0.01% LISTSYNAPRYN SUS 10MG/ML Unapproved DrugSYNERDERM EMU Not properly listed with FDASYNVEXIA TC CRE 4-1% Unapproved DrugSYNVISC INJ 8MG/ML Surgical Supply/MedicalSYNVISC ONE INJ 8MG/ML Surgical Supply/MedicalSYRPALTA SYP Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
SYRPALTA SYP CLEAR Not properly listed with FDASYRSPEND SF LIQ Bulk IngredientSYRUP SYP VEHICLE Not properly listed with FDASYRUP SF SYP VEHICLE Not properly listed with FDATABRADOL SUS 1MG/ML Unapproved DrugTABRADOL SUS RAPIDPAQ Unapproved DrugTACROLIMUS CRE MONOHYDR Unapproved DrugTADALAFIL TAB 10MG Erectile DysfunctionTADALAFIL TAB 2.5MG* [Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only.] Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]TADALAFIL TAB 20MG* [Coverable for Pulmonary Arterial Hypertension (PAH) diagnosis only.] Erectile Dysfunction [only coverable for diagnosis of Pulmonary Arterial Hypertension (PAH)]TADALAFIL TAB 5MG* [Coverable for Benign Prostatic Hyperplasia (BPH) diagnosis only.] Erectile Dysfunction [only coverable for diagnosis of Benign Prostatic Hyperplasia (BPH)]TAGITOL V SUS 40% Diagnostic AgentTALIVA CAP Vitamin/MineralTALL RAGWEED SOL 1:20 Non-standardized allergenicTANDEM F CAP Vitamin/MineralTARDEOXIA CRE Not properly listed with FDATARDIMAXIA GEL Not properly listed with FDATARON GRA CRYSTALS Unapproved DrugTARON-BC MIS Vitamin/MineralTARON-C DHA CAP Vitamin/MineralTARON-PREX CAP Vitamin/MineralTAROXIA CRE Not properly listed with FDATASOPROL KIT LISTTAURINE INJ 50MG/ML Unapproved DrugTDC MAX CRE Not properly listed with FDATDM SOLUTION SOL Not properly listed with FDATECARTUS SUS LISTTECHNELITE KIT HEU Diagnostic AgentTECHNELITE KIT LEU Diagnostic AgentTEGADERM AG PAD 2"X2" Not properly listed with FDATEGADERM AG PAD 4"X5" Not properly listed with FDATEGADERM AG PAD 4"X8" Not properly listed with FDATEGADERM AG PAD 8"X8" Not properly listed with FDATELFA ISLAND PAD 4"X5" Not properly listed with FDATELFA ISLAND PAD 4"X8" Not properly listed with FDATEMODAR CAP 100MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 140MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 180MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 20MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 250MG Oral drug for cancer; infusion available under Part BTEMODAR CAP 5MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 100MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 140MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 180MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 20MG Oral drug for cancer; infusion available under Part B
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
TEMOZOLOMIDE CAP 250MG Oral drug for cancer; infusion available under Part BTEMOZOLOMIDE CAP 5MG Oral drug for cancer; infusion available under Part BTERODERM CRE Not properly listed with FDATERODERM CRE PLUS Not properly listed with FDATERRELL SOL General AnestheticTESSALON PER CAP 100MG Cough/ColdTESTONE CIK KIT 200MG/ML LISTTESTOST CYP INJ 200MG/ML Not properly listed with FDATESTOSTERONE CRE Not properly listed with FDATESTOSTERONE INJ 100MG/ML (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ 150MG/ML (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ 200MG/ML (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ CYP/PROP (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ CYPIONAT (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ CYPIONAT (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE INJ CYPIONAT (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE MIS 100MG (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE MIS 200MG (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE MIS 25MG (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTESTOSTERONE MIS 50MG (MANUFACTURED BY EMPOWER PHARMACY) Unapproved DrugTETRACAINE INJ 1% Unapproved DrugTETRIX CRE Not properly listed with FDATEXAVITE LQ LIQ Vitamin/MineralTHALLOUS INJ TL 201 Diagnostic AgentTHALLOUS CL INJ TL 201 Diagnostic AgentTHERAHONEY GEL Not properly listed with FDATHERAHONEY MIS 4"X5" Not properly listed with FDATHERAMINE CAP Medical FoodTHERAMINE POW PLUS Medical FoodTHIAMINE HCL INJ 100MG/ML Vitamin/MineralTHRIVACIN LIQ DETOX Vitamin/MineralTHRIVACIN 30 LIQ Vitamin/MineralTHRIVITE 19 TAB Vitamin/MineralTHRIVITE RX TAB 29-1MG Vitamin/MineralTHROMBIN KIT 5000UNIT Blood ComponentTHROMBIN-JMI KIT 20000UNT Blood ComponentTHROMBIN-JMI KIT 5000UNIT Blood ComponentTHROMBIN-JMI SOL 20000UNT Blood ComponentTHROMBIN-JMI SOL 5000UNIT Blood ComponentTICALAST KIT 137/50 LISTTICANASE PAK 50-2.7 LISTTICASPRAY PAK LISTTIGHTENING CRE BASE Not properly listed with FDATIMOTHY SOL GRASS Non-standardized allergenicTIMOTHY GRAS INJ 10000BAU Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
TIMOTHY GRAS SOL POLLEN LISTTISSEEL KIT 2ML Not properly listed with FDATISSEEL VH KIT 2ML Blood ComponentTIZANIDINE KIT COMFORT LISTTL FOLATE TAB Vitamin/MineralTL GARD RX TAB Vitamin/MineralTL G-FOL OS TAB Vitamin/MineralTL HYDROQUIN CRE 4% CosmeticTL ICON CAP Vitamin/MineralTL-CARE DHA CAP 27-1-500 Vitamin/MineralTL-FLUORIVIT CHW Vitamin/MineralTL-HEM 150 TAB Vitamin/MineralTL-ICARE CAP Medical FoodTL-SELECT CAP Vitamin/MineralTOBAIKIENT CAP Dietary SupplementTOMATO INJ EXTRACT Diagnostic AgentTOPEX TOPCAL AER ANESTHET Unapproved DrugTOPIDEX KIT 10MG/1ML LISTTORONOVA KIT 30MG/ML LISTTORONOVA II KIT 30MG/ML LISTTOVET KIT KIT 0.05% LISTTOXICOL SALV KIT COLLECT Diagnostic AgentTOXICOLOGY KIT MEDICATE Diagnostic AgentTRACE ELEM 4 INJ PED Unapproved DrugTRALEMENT INJ LISTTRAMADOL CRE 5% Bulk IngredientTRAMADOL CRE 8% KIT Bulk IngredientTRANSDERMAL CRE PAIN BAS Not properly listed with FDATRANZGEL GEL Unapproved DrugTRAUMEEL INJ Unapproved DrugTRAUMEEL OIN Unapproved DrugTRAUMEEL TAB Unapproved DrugTREPADONE CAP Unapproved DrugTRETINOIN EM CRE 0.05% CosmeticTRETTEN INJ Blood ComponentTRIAM/MOXI SUS 15-1 Unapproved DrugTRI-AMINO INJ Unapproved DrugTRIAMSIL PAK COMBIPAK Not properly listed with FDATRIAMSIL PAK MULTIPAK Not properly listed with FDATRICARE TAB PRENATAL Vitamin/MineralTRICARE PRE CAP 27-1-500 Vitamin/MineralTRICARE PREN CAP DHA ONE Vitamin/MineralTRI-CHLOR LIQ 80% Unapproved DrugTRICHOPHYTON INJ 1:200 Diagnostic AgentTRICHOPHYTON SOL 20000PNU Non-standardized allergenic
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
TRICITRASOL CON LISTTRICITRATES SOL Unapproved DrugTRICON CAP Vitamin/MineralTRICOPHYTON SOL MENTAGRO LISTTRIFERIC POW 272MG Vitamin/MineralTRIFERIC SOL 27.2/5ML LISTTRILOAN II KIT 40MG/ML LISTTRILOAN SUIK KIT 40MG/ML LISTTRI-LUMA CRE CosmeticTRI-MIX INJ Erectile DysfunctionTRIMO-SAN GEL Unapproved DrugTRINATAL RX TAB 1 Vitamin/MineralTRINATE TAB Vitamin/MineralTRINAZ TAB 12-1MG Vitamin/MineralTRIPHROCAPS CAP Vitamin/MineralTRIPLE COMPL CRE 3 KIT Not properly listed with FDATRIPLE PMB SOL Not properly listed with FDATRIPLE PMK SOL Not properly listed with FDATRISTART DHA CAP Vitamin/MineralTRISTART ONE CAP 35-1-215 Vitamin/MineralTRI-TABS DHA MIS Vitamin/MineralTRIVEEN-DUO PAK DHA Vitamin/MineralTRI-VI-FLOR SUS 0.25/ML Vitamin/MineralTRI-VI-FLOR SUS 0.5MG/ML Vitamin/MineralTRI-VI-FLORO SUS 0.25/ML Vitamin/MineralTRI-VI-FLORO SUS 0.5MG/ML Vitamin/MineralTRI-VIT/FLUO DRO 0.25MG Vitamin/MineralTRI-VIT/FLUO DRO 0.5MG Vitamin/MineralTRIVIX KIT Unapproved DrugTRIXYLITRAL MIS LISTTRONVITE TAB Vitamin/MineralTROP-CYC-PE DRO 1-1-2.5 Unapproved DrugTROPICAMIDE SOL 0.5% OP Diagnostic AgentTROPICAMIDE SOL 1% OP Diagnostic AgentTROP-PROP-PE DRO KETO Unapproved DrugTRYPTOPHAN CAP 500MG Unapproved DrugT-SUPPORT CAP MAX Medical FoodTUBERSOL INJ 5/0.1ML Diagnostic AgentTUSSICAPS CAP 10-8MG Cough/ColdTUSSIONEX SUS 10-8/5ML Cough/ColdTUXARIN ER TAB 54.3-8MG LISTTUZISTRA XR SUS Cough/ColdTYLACTIN LIQ REST 10 Not properly listed with FDATYLACTIN LIQ RTD 15 Not properly listed with FDATYLACTIN POW BLD 20PE Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
TYLACTIN POW RESTOR5 Not properly listed with FDATYLACTIN COM BAR 15 PE Not properly listed with FDATYR EASY TAB Not properly listed with FDAUDAMIN SP TAB Vitamin/MineralULTANE SOL General AnestheticULTIMATECARE CAP ONE Vitamin/MineralULTRABAG/ SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/ SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRABAG/PD2 SOL DIANEAL Dialysis covered by ESRD bundled paymentULTRADERM CRE Not properly listed with FDAULTRASAL-ER SOL 28.5% Unapproved DrugULTRAVIST INJ 240MG/ML Diagnostic AgentULTRAVIST INJ 300MG/ML Diagnostic AgentULTRAVIST INJ 370MG/ML Diagnostic AgentUMECTA MOUSS AER 40% Unapproved DrugU-MILD SHA Not properly listed with FDAUNISPEND ANH SUS SWEETENE Not properly listed with FDA UNIVERSAL GEL WATER Not properly listed with FDAURALISS CRE 35% Not properly listed with FDAURAMAXIN GEL 45% Unapproved DrugURAMIT MB CAP 118MG Unapproved DrugURE-39 CRE 39% Not properly listed with FDAUREA AER 35% Not properly listed with FDAUREA CRE 39% Unapproved DrugUREA CRE 40% Unapproved DrugUREA CRE 41% Unapproved DrugUREA CRE 45% Unapproved DrugUREA CRE 47% Unapproved DrugUREA EMU 50% Unapproved DrugUREA GEL 40% Unapproved DrugUREA LOT 40% Unapproved DrugUREA LOT 45% Unapproved DrugUREA HYDRATI AER 35% Unapproved DrugUREA NAIL GEL 45% Unapproved DrugUREA TOPICAL SUS 40% Unapproved DrugUREA-C40 LOT 40% Unapproved DrugUREDEB CRE 39% Not properly listed with FDAURE-K CRE 50% Unapproved DrugURELLE TAB Unapproved DrugUREMEZ-40 CRE 40% Not properly listed with FDAURESOL CRE 42.5% Not properly listed with FDAURETRON D/S TAB Unapproved DrugURETRON D/S TAB Unapproved Drug
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
URIBEL CAP 118MG Unapproved DrugURIMAR-T TAB Unapproved DrugURIN D/S TAB Unapproved DrugURO-458 TAB Unapproved DrugUROGESIC- TAB BLUE Unapproved DrugURO-MP CAP 118MG Unapproved DrugUROPHEN MB TAB 81.6MG Unapproved DrugUROSEX TAB Vitamin/MineralURSODIOL SUS 30MG/ML Not properly listed with FDAURYL TAB Unapproved DrugUSTELL CAP Unapproved DrugUTA CAP 120MG Unapproved DrugUTA CAP 120MG Unapproved DrugUTICAP CAP Unapproved DrugUTIRA-C TAB Unapproved DrugUTOPIC CRE 41% Unapproved DrugUTRONA-C TAB Unapproved DrugVACUSTIM KIT BLACK LISTVACUSTIM KIT SILVER LISTVANCOMYC/D5W INJ 1.25/250 Not properly listed with FDAVANCOMYC/D5W INJ 1.5/250 Not properly listed with FDAVANCOMYCIN SUS +SYRSPEN Not properly listed with FDAVANCOMYCIN HCL IV SOLN 1000 MG/10ML Unapproved DrugVANCOMYCIN HCL IV SOLN 1250 MG/12.5ML Unapproved DrugVANCOMYCIN HCL IV SOLN 1500 MG/15ML Unapproved DrugVANCOMYCIN HCL IV SOLN 1750 MG/17.5ML Unapproved DrugVANCOMYCIN HCL IV SOLN 2000 MG/20ML Unapproved DrugVANCOMYCIN HCL IV SOLN 750 MG/7.5ML Unapproved DrugVANCOSOL KIT 1GM-0.9% Not properly listed with FDAVANIQA CRE 13.9% CosmeticVANISHING CRE Not properly listed with FDAVANISHING CRE BOTANCAL Not properly listed with FDAVANISH-PEN CRE Not properly listed with FDAVANOXIDE-HC LOT 5-0.5% Unapproved DrugVARDENAFIL TAB 10MG Erectile DysfunctionVARDENAFIL TAB 10MG ODT Erectile DysfunctionVARDENAFIL TAB 2.5MG Erectile DysfunctionVARDENAFIL TAB 20MG Erectile DysfunctionVARDENAFIL TAB 5MG Erectile DysfunctionVARDIMAXIA GEL Not properly listed with FDAVARIBAR PST PUDDING Diagnostic AgentVARIBAR HONE SUS 40% Diagnostic AgentVARIBAR NECT SUS 40% Diagnostic AgentVARIBAR THIN SUS HONEY Diagnostic AgentVARIBAR THIN SUS LIQUID Diagnostic Agent
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
VARITHENA AER 10MG/ML LISTVAROPHEN KIT 1.5% LISTVAROXIA CRE Not properly listed with FDAVAROXIA GEL Not properly listed with FDAVASCAZEN CAP 1GM Not properly listed with FDAVASCULERA TAB Medical FoodVASHE CLEANS SOL Not properly listed with FDAVAYACOG CAP Not properly listed with FDAVAYARIN CAP Not properly listed with FDAVAYARIN PLUS CAP Not properly listed with FDAVAYAROL CAP Not properly listed with FDAVB6 P5P POW Not properly listed with FDAV-C FORTE CAP Vitamin/MineralVECURONIUM INJ 10MG LISTVECURONIUM INJ 20MG LISTVECURONIUM POW Not properly listed with FDAVEG CAPSULE CAP #0 WHITE Unapproved DrugVEG CAPSULE CAP #00 WHIT Unapproved DrugVEG CAPSULE CAP #1 GREEN Unapproved DrugVEG CAPSULE CAP #1 WHITE Unapproved DrugVEG CAPSULE CAP #2 WHITE Unapproved DrugVEG CAPSULE CAP #3 WHITE Unapproved DrugVEG CAPSULE CAP #4 WHITE Unapproved DrugVENA-BAL MIS DHA Vitamin/MineralVENELEX OIN DeviceVENIPUNCTURE KIT CPI LISTVENIPUNCTURE KIT PHLEBOTO Not properly listed with FDAVENNGEL ONE KIT 1% LISTVENOFER INJ 20MG/ML Vitamin/MineralVENOMIL KIT HONEYBEE Non-standardized allergenicVENOMIL KIT HONEYBEE Non-standardized allergenicVENOMIL KIT WASP Non-standardized allergenicVENOMIL KIT WASP Non-standardized allergenicVENOMIL KIT WHT HORN Non-standardized allergenicVENOMIL KIT WHT HORN Non-standardized allergenicVENOMIL KIT YEL HORN Non-standardized allergenicVENOMIL KIT YEL HORN Non-standardized allergenicVENOMIL KIT YEL JACK Non-standardized allergenicVENOMIL KIT YEL JACK Non-standardized allergenicVENOMIL MIX INJ VESPID Non-standardized allergenicVERSAFREE SYP Not properly listed with FDAVERSAPLUS SYP Not properly listed with FDAVERSAPRO AER Not properly listed with FDAVERSAPRO CRE Bulk IngredientVERSAPRO SHA Not properly listed with FDA
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
VERSATILE CRE BASE Bulk IngredientVERSATILE CRE RICH BSE Bulk IngredientVEXASYN GEL Not properly listed with FDAVEXATROL KIT 2.5-2.5% Not properly listed with FDAVIAGRA TAB 100MG Erectile DysfunctionVIAGRA TAB 25MG Erectile DysfunctionVIAGRA TAB 50MG Erectile DysfunctionVIC-FORTE CAP Vitamin/MineralVILACTIN AA LIQ PLUS Not properly listed with FDAVILAMIT MB CAP 118MG Unapproved DrugVILEVEV MB TAB 81MG Unapproved DrugVIL-RX TAB 29-1MG Vitamin/MineralVINATE DHA CAP 27-1.13 Vitamin/MineralVINATE II TAB Vitamin/MineralVINATE M TAB Vitamin/MineralVINATE ONE TAB Vitamin/MineralVIRASAL LIQ 27.5% Unapproved DrugVIRGINIA INJ LIVE OAK Non-standardized allergenicVIRT-C DHA CAP Vitamin/MineralVIRT-CAPS CAP Vitamin/MineralVIRT-GARD TAB 2.2-25-1 Vitamin/MineralVIRT-NATE CAP DHA Vitamin/MineralVIRT-PHOS TAB 250 NEUT Vitamin/MineralVIRT-PN TAB Vitamin/MineralVIRT-PN DHA CAP Vitamin/MineralVIRT-PN PLUS CAP Vitamin/MineralVISBIOME PAK Not properly listed with FDAVISIPAQUE INJ 270MG/ML Diagnostic AgentVISIPAQUE INJ 320MG/ML Diagnostic AgentVIT A/C/D/FL DRO 0.25MG Vitamin/MineralVITA S FORTE TAB Vitamin/MineralVITACEL TAB Vitamin/MineralVITAFOL CAP ULTRA Vitamin/MineralVITAFOL CHW GUMMIES Vitamin/MineralVITAFOL TAB Vitamin/MineralVITAFOL FE+ CAP Vitamin/MineralVITAFOL STRP MIS 1MG Vitamin/MineralVITAFOL-NANO TAB Vitamin/MineralVITAFOL-OB PAK +DHA Vitamin/MineralVITAFOL-OB TAB 65-1MG Vitamin/MineralVITAFOL-ONE CAP Vitamin/MineralVITAL-D RX TAB Vitamin/MineralVITAMAX PED DRO Vitamin/MineralVITAMEDMD CAP ONE RX Vitamin/MineralVITAMEZ CAP Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
VITAMIN KIT SYS-B12 LISTVITA-MIN CAP Vitamin/MineralVITAMIN D CAP 1.25MG LISTVITAMIN D CAP 50000 Vitamin/MineralVITAMIN D CAP 50000UNT Vitamin/MineralVITAMIN K1 INJ 10MG/ML Vitamin/MineralVITAMIN K1 INJ 1MG/0.5 Vitamin/MineralVITAPEARL CAP Vitamin/MineralVITA-PREN TAB Vitamin/MineralVITAROCA PLU TAB Vitamin/MineralVITASURE TAB Vitamin/MineralVITATHELY TAB Vitamin/MineralVITATRUE MIS Vitamin/MineralVITAXYME TAB Vitamin/MineralVITREXATE TAB Multi-vitaminVITREXATE FE TAB Multi-vitaminVITREXYL TAB Multi-vitaminVITREXYL TAB IRON Multi-vitaminVIVA DHA CAP Vitamin/MineralVIZAMYL INJ Diagnostic AgentVOL-CARE RX TAB Vitamin/MineralVOL-NATE TAB Vitamin/MineralVOL-PLUS TAB Vitamin/MineralVOL-TAB RX TAB Vitamin/MineralVOLUMEN SUS 0.1% Diagnostic AgentVOLUMEX INJ 25/ML Diagnostic AgentVONVENDI INJ 1300UNIT Blood ComponentVONVENDI INJ 650UNIT Blood ComponentVOPAC MDS KIT 1.5% LISTVP FC CRE KIT Not properly listed with FDAVP GKL CRE KIT Not properly listed with FDAVP-HEME OB MIS + DHA Vitamin/MineralVP-PNV-DHA CAP Vitamin/MineralVP-VITE RX TAB Vitamin/MineralVSL#3 DS PAK 900BIL Not properly listed with FDAVYLEESI INJ 1.75/0.3 LISTVYTONE CRE 1-1.9% DESIWASP VENOM INJ 1100MCG Non-standardized allergenicWASP VENOM INJ 120MCG Non-standardized allergenicWASP VENOM INJ 1300MCG Non-standardized allergenicWASP VENOM INJ 550MCG Non-standardized allergenicWATER BASE GEL Not properly listed with FDAWELLMIND TAB VERTIGO Unapproved DrugWESTAB MAX TAB 2.5-25-2 Vitamin/MineralWESTAB MINI TAB 2.2-25-1 Vitamin/Mineral
Label Name Reason
MEDICARE PART D EXCLUDED DRUGS LIST 2021_updated January 2021
Reason: LIST = multiple reasons it's excluded; "not covered under Part D law"
Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage
determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.
Reason: DESI = Less Than Effective (LTE) drug for ALL indications
WESTAB ONE TAB 2.5-25-1 Vitamin/MineralWESTAB PLUS TAB 27-1MG Vitamin/MineralWESTERN JUNI SOL 1:20 Non-standardized allergenicWESTGEL DHA CAP Multi-vitamin w/ ironWESTHROID TAB 130MG Unapproved DrugWESTHROID TAB 195MG Unapproved DrugWESTHROID TAB 32.5MG Unapproved DrugWESTHROID TAB 65MG Unapproved DrugWESTHROID TAB 97.5MG Unapproved DrugWHEAT GERM OIL Not properly listed with FDAWHITE ASH INJ EXTRACT Non-standardized allergenicWHITE BIRCH INJ 1:20 Non-standardized allergenicWHITE FACED INJ HORNET Non-standardized allergenicWHITE FACED INJ HORNET Non-standardized allergenicWHITE MULBER SOL 1:20 Non-standardized allergenicWHITE OAK SOL Non-standardized allergenicWHITE PINE INJ 1:20 Non-standardized allergenicWHOLE EGG INJ EXTRACT Diagnostic AgentWIDE-SEAL DPR KIT 60 DeviceWIDE-SEAL DPR KIT 65 DeviceWIDE-SEAL DPR KIT 70 DeviceWIDE-SEAL DPR KIT 75 DeviceWIDE-SEAL DPR KIT 80 DeviceWIDE-SEAL DPR KIT 85 DeviceWIDE-SEAL DPR KIT 90 DeviceWIDE-SEAL DPR KIT 95 DeviceWILATE INJ Blood ComponentWOUND KIT DEBRIDEM LIST
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