The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.
(NOTE: New field “ProductID” added 8/23/2013 in Product and package files.)
–
New NDC Directory
Search National Drug Code Directory
Searchable database
NDC Database File (Zip Format) (ZIP – 13.6MB) Updated 10/31/2013
NDC Product File Definitions
Product File Data Elements, Definitions, and Notes
NDC Package File Definitions
Package File Data Elements, Definitions, and Notes
–
–
Old NDC Directory
Old NDC Database File (Zip Format) (ZIP – 4.8MB) [ARCHIVED]
Data Files Updated through July 2012 (Final Update)
Search OLD National Drug Code Directory
–
Current regulations require a registered establishment to update its drug listing data in June and December of each year, or, at the discretion of the establishment, when a change occurs (see 21 C.F.R. § 207.30); therefore, FDA may not yet have been notified of recent changes before updating the NDC Directory. FDA makes every effort to prevent errors and discrepancies in the NDC Directory data. Users who detect any errors are requested to contact:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance, Immediate Office
Drug Registration and Listing Team
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Email: eDRLS@fda.hhs.gov