Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). Drug establishments are required to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S. at their designated facilities. An NDC is a 10 digit number that uniquely and universally identifies a drug product by stringing together three separate code segments with hyphens. A complete NDC is made up of a labeler code, a product code and package code segment, with dashes between each segment.
The NDC Directory contains product data submitted for all completed drugs including prescription and over-the-counter drugs, approved and unapproved drugs, and repackaged and relabeled drugs.
- The first segment of National Drug Codes, the labeler code, is assigned by the FDA. A labeller is anyone that manufactures (including re-packers or relabelers), or distributes the drug (under its own name).
- The second segment, the product code, lists the specific strength, dosage form, and formulation of a drug. Different formulations or different strengths of the same formulation should be given different product codes. Drug products that share the same formulation but have different product features that clearly distinguish one drug product version from another must also have a different product code under the same label code.
- The third segment of National Drug Codes, the package code, identifies the package size and type. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.
The NDC Directory does not contain all listed drugs; however, it does contain all over-the-counter (OTC) medications, prescription medications, and insulin packages in the U.S.A. Animal drugs, blood products, and human drugs not in final marketed form will not be included in the directory. It is important to note that having an NDC does not equate to approval from the FDA.
Reed Tech subject-matter expert, David Wilson, breaks down the basics of the NDC structure here in the first of a series of Insights.