NDC DirectoryFDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
Orange BookApproved Drug Products with Therapeutic Equivalence Evaluations
Purple BookThe Purple Book is available as lists and a database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products.
REMS@FDAThe Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
Mobile Applications
Drugs@FDA Express mobile appThis is the app version of the Drugs@FDA database that provides information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products.
FDA Drug Shortages Mobile AppThe app identifies current drug shortages, resolved shortages and discontinuations of drug products.
FDA NDC Express AppSearching the NDC Directory is now faster and easier with the new mobile app!
FDA Orange Book Express 2.0 Mobile AppThe new app makes it easy and convenient to view The Approved Drug Products with Therapeutic Equivalence Evaluations list. This list is most commonly known as the “Orange Book.”
Updates from the FDA
MedWatch Safety Alerts
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Press Releases
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Tainted Products That are Marketed as Dietary Supplements
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Additional Resources
These websites have been chosen because they provide unbiased information or standards of practice from government agencies or national organizations.
ClinicalTrials.govClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. Published by the National Library of Medicine.
DailyMedDailyMed provides high quality information about marketed drugs. This information includes FDA labels (package inserts).
