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.ĭrug establishments producing active pharmaceutical ingredients are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed in commercial distribution in the U.S. A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label. The NDC Directory contains information on active and certified finished and unfinished drugs submitted to FDA in structured product labeling (SPL) electronic listing files by labelers. FDA publishes the listed NDC numbers in the NDC Directory which is updated daily. Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. Searching the NDC Directory is now faster and easier with our new mobile app!ĭirectorio de Códigos Nacionales de Medicamentos (Spanish Version)įDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products.ĭrug establishments are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.S.

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