National Drug Code

Acronym: NDC

A medical code set maintained by the Food and Drug Administration that contains codes for drugs that are FDA approved. The Secretary of HHS adopted this code set as the standard for reporting drugs and biologics on standard transactions. Drug products are identified and reported using the NDC. The National Drug Code is a unique 11-digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers 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 cannot 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. [The National Drug Code (NDC) Rules for Assigning and Changing NDCs](https://www.fda.gov/media/154502/download)