what is ndc

what is ndc

1 year ago 67
Nature

The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The NDC is a 10-digit or 11-digit, 3-segment number that identifies the labeler, the product, and the commercial package size. The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributor. The second set of numbers is the product code, which identifies the specific strength, dosage form, and formulation of a drug for a specific labeler. The third set of numbers is the package code, which identifies the package size.

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 facilities. Drugs are identified and reported using the NDC, which serves as the FDA’s identifier for drugs. The FDA publishes the listed NDC numbers in the NDC Directory, which is updated daily. The NDC Directory contains information on active and certified finished and unfinished drugs submitted to the FDA in structured product labeling (SPL) electronic listing files by labelers. The NDC Directory contains product listing data submitted for all finished drugs, including prescription and over-the-counter drugs, approved and unapproved drugs, and repackaged and relabeled drugs.

The NDC is used to identify drugs in the U.S. and is not related to the Nationally Determined Contributions (NDCs) for climate action plans or the New Distribution Capability (NDC) for airlines.

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