Claim: The National Drug Code (NDC) is a unique ten or eleven digit, three-segment numeric identifier, with the first segment being the labeler code (assigned by the FDA); the second segment being the product code (assigned by the labeler); and the third segment being the package code (also assigned by the labeler).
Evidence: The National Drug Code is a unique 10 or 11 digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The first segment, the labeler code, is 4, 5 or 6 digits long and assigned by the Food and Drug Administration (FDA) upon submission of a Labeler Code Request. A labeler is any firm that manufactures, repacks or distributes a drug product. The second segment, the product code, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional cases, product and package segments may have contained characters other than digits. While the labeler code is assigned by the FDA, both the product and package segments are assigned by the labeler. The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use.