Who Assigns the NDC Digits?
FDA assigns the first segment of national drug code (NDC) digits, known as the labeler code. A labeler is any firm that manufactures, repackages, or distributes a drug product. The second segment, assigned by the labeler and known as the product code, identifies the specific strength, dosage form, and formulation. The package code, the third segment of digits, identifies the package size. Like the second segment, the third segment is assigned by the labeler.
