TM Pharmaceutical Primer WHAT IS AN NDC? NDC is an acronym for National Drug Code. The NDC directory was established by the US Food and Drug Administration to serve as a universal product identifier for human drugs. Each drug product listed under Section 510 of the Federal Food, Drug and Cosmetic Act is assigned a unique 10 or 11-digit, 3-segment number. This number, or NDC, identifies three aspects of the drug, as illustrated below. ■ ■ ■ National Drug Code (NDC) Primer PHARMACEUTICAL SERVICES TM Who We Are Strong Pharmaceutical Services, a division of Strong Environmental, Inc., is the leading provider of destruction services to the pharmaceutical industry. Our experienced professionals manage and ensure the appropriate witnessed destruction of DEA controlled substances, as well as proper disposition of RCRA hazardous and non- hazardous finished goods and manufacturing wastes. When we take control of waste materials at your shipping dock, they become our full responsibility. Stron Pharmaceutical Services: Secure Pharmaceutical Destruction Solutions Strong Pharmaceutical Services a division of Strong Environmen tal, Inc. 6264 Crooked Creek Road Norcross, GA 30092 770.409.1500 800.778.7664 www.StrongPharma.com [email protected] © Copyrig ht 2008,Strong Environ menta l, Inc. LABELER CODE PRODUCT CODE PACKAGE CODE LABELER CODE: Identifies the firm that manufactures, repacks, or distributes that particular drug product. PRODUCT CODE: Identifies a specific strength, dosage form, and formulation for a particular labeler. PACKAGE CODE: Identifies package size. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, 5-4-1 or 5-4-2. The example at bottom left illustrates the 5-4-2 format. Formats may include leading zeros. Both the product and package codes are assigned by the labeler. WHAT DOES A “**” MEAN AT THE END OF AN NDC? The “**” indicates a bulk solid or bulk liquid product. In the case of finished goods, it is typically a single solid unit dose (tablet, vial, capsule), or a ml of liquid. WHERE CAN I FIND MORE INFORMATION ABOUT NDCs? http://www.fda.gov/cder/ndc REGULATED PHARMACEUTICALS CHART As a service to the pharmaceutical manufacturing and distribution community, Strong publishes our Regulated Pharmaceuticals Chart, illustrated above right, which includes the contents of this primer, as well as more information about hazardous pharmaceutical wastes, regulatory agencies, controlled substances, listed chemicals and more. To request a copy of the poster for your reference, please contact Strong at 770.409.1500, or via e-mail at Solutions@ StrongServices.com. To request a copy of the poster for your reference, please contact Strong at