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 by USFDA
- Search National Drug Code Directory
Searchable database - NDC Database File (Zip Format) (ZIP - 15.6MB)
Updated 08/19/2014 - NDC Product File Definitions
Product File Data Elements, Definitions, and Notes - NDC Package File Definitions
Package File Data Elements, Definitions, and Notes
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