Drug establishments that are engaged in manufacturing, preparation, propagation, compounding, or processing a drug are required to register their establishments and list all of their commercially marketed drug products.
What is drug listing?
Detailed information about any drug products made for commercial distribution must be provided to the FDA by registered drug companies. The National Drug Code is used to keep track of drug products.
What is FDA drug listing?
Drug listing data can be submitted electronically using the structured product labeling format. This gives the agency a list of all the drugs that are currently available for sale in the U.S.
What is the purpose of the National Drug Code?
The National Drug Code is used by the FDA to identify and report drugs. NDC numbers are listed in the FDA’s NDC Directory.
What is the Pure Food and Drug Act?
The FDA was formed because of the Pure Food and Drug Act of 1906, which banned the sale of adulterated or mis branded food and drugs.