The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for human drugs.
Each listed drug product is assigned a unique 10-digit, 3-segment number†. This number, known as the NDC, identifies the labeler, product, and trade package size.
The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including re-packers or relabelers), or distributes (under its own name) the drug.
The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug for a particular firm. Different formulations or different strengths of the same formulation should be assigned different product codes. This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes. Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code.
The third segment, the package code, identifies package sizes and types. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.
Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1†.
† note In Find-A-Code, all NDCs are formatted into an 11-digit, 3-segment number with a 5-4-2 configuration. To format an NDC from 10 digits to 11 digits, simply add a zero (0) at the beginning of the necessary segment to match the 5-4-2 pattern.
Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR 207.39)
Neither inclusion in the NDC Directory nor assignment of an NDC number is a determination that a product is a drug as defined by the FD&C Act, nor does either denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
The NDC Directory does not contain all listed drugs. It does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as active pharmaceutical ingredients, or drugs that are marketed solely as part of a kit or combination product or inner layer of a multi-level packaged product.