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). 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 does not contain all listed drugs; however, will 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.