The American Academy of Pediatrics Coding Hotline has received many questions about the use of the National Drug Code (NDC). We thought that practices may benefit from the following primer on the NDC system.

The NDC includes national product identifiers for drugs approved for human use in the United States. The Drug Listing Act of 1972 was enacted to provide the commissioner of the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic (FD&C) Act.

Each drug product listed under the FD&C Act is assigned a unique 10-digit, 3-segment number—the NDC. The NDC identifies the labeler, product, and package size.

Product and package codes are assigned by the firm. Therefore, the same drug or vaccine will have different NDCs depending on, for example, the package size and dosage (see...

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