Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. Outsourcing facilities may, but are not required to, assign NDCs to their finished compounded human drug products. Outsourcing facilities – a type of drug compounding facility regulated under Section 503B of the FD&C Act – can be eligible for exemptions from drug registration and listing requirements if they meet the conditions under Section 503B. The NDC Directory also includes information about finished compounded human drug products produced by outsourcing facilities that have elected to assign NDCs to their products. The NDC unfinished drugs database contains product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding. 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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