Identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

FDA’s Global Substance Registration System enables efficient and accurate exchange of information on substances through their Unique Ingredient Identifiers (UNIIs) which can be generated at any time in the regulatory life cycle.

This is the full RxNorm monthly data release. Requires (free) UMLS license.

RxTerms is a drug interface terminology derived from RxNorm for prescription writing or medication history recording (e.g. in e-prescribing systems, PHRs).

Product listing data submitted for all finished drugs including prescription and over-the-counter drugs, approved and unapproved drugs and repackaged and relabeled drugs.

Products removed / excluded from the NDC Directory for failure to respond to FDA’s requests for correction for various reasons.

Product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding.

Formulary, pharmacy network, and pricing data for Medicare Prescription Drug Plans and Medicare Advantage (MA) Prescription Drug Plans (with the exception of employer and Program of All-Inclusive Care for the Elderly plans).

Drug products with therapeutic equivalence evaluations approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

Information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.

FDA recall data, also known as enforcement reports.

These files map DailyMed SPLs to various things like RxNorm concepts, pharmacologic classes, and zip file metadata.

Also known as ATCPROD. ATC4 codes to product RXCUIs as mapped by NLM.

Historical NDCs mapped to product RXCUIs with start and end dates and indirect RXCUI linkages.