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U.S. Department of Health and Human Services

Drugs

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Determining if a Drug is FDA Approved

 Orange Book:
The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), 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). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication.

If you know the trade name:

  • select the link "Search by Proprietary Name"
  • in the "Search by Proprietary Name" field, type in part or all of the brand (proprietary) name of the product
  • select the list (prescription (Rx), over-the-counter (OTC), or discontinued products) you would like to search
  • click on the "Submit" button
  • your search results will appear
    • If the product is FDA approved, then the resulting list will provide approved products (note the application number in the "Appl No" column) by dosage form, route, and name of applicant
    • If the product is not in the FDA approved list, then the results will state, "No matching records found."

If you know the active ingredients of the product:

  • select the link "Search by Active Ingredient"
  • in the "Search by Active Ingredient" field, type in part or all of the active ingredient
  • select the list (prescription (Rx), over-the-counter (OTC), or discontinued products) you would like to search
  • click on the "Submit" button
  • your search results will appear
    • If the product is FDA approved, then the resulting list will provide approved products (note the application number in the "Appl No" column) by dosage form, route, and name of applicant
    • If the product is not in the FDA approved list, then the results will state, "No matching records found." 

National Drug Code (NDC) Directory:
FDA makes information available to the public about drug establishments and products through the NDC Directory. The NDC Directory is limited to prescription drugs and insulin products. The NDC, a unique ten-digit number, serves as a universal product identifier for human drugs in commercial distribution. FDA assigns the first five digits (known as the labeler code) and the registrant assigns the last 5-digits (known as the product and package code). Assignment of an NDC number does not denote approval of the product.

To determine if a product has FDA approval, individuals can search the NDC directory using a number of different categories. Search results from the NDC directory contain a column marked "Application Number." If a prescription drug product (including insulin) is approved by FDA, an NDA or ANDA number will be included in this column. All other products (including biological products approved under section 351 of the Public Health Service Act) are identified as "other" in the Application Number column of the display. Identification of a drug product as "other" indicates that the product has not been approved for safety and effectiveness by the FDA (unless there is a data error or the firm did not provide the product's application number). A manufacturer can clarify whether its drug has FDA approval by, among other things, providing the application number for the approved product.

 Drugs@FDA:
Drugs@FDA is a catalog of FDA-approved drug products, as well as drug labeling. Drugs@FDA contains most of the drug products approved since 1939.

 Legal mechanisms to access unapproved drugs:

Reporting adverse drug events:

In order to keep effective drugs and devices available on the market for use by you and your patients, the FDA relies on the voluntary reporting of adverse drug events, via the FDA's MedWatch Program. FDA uses this data to maintain our safety surveillance of all FDA-regulated products. Your report may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the drug or device, and leads to increased patient safety.

The FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care, not events that occur during IND clinical trials or other clinical studies. Those mandatory reports are to be submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions. For instructions on mandatory reporting, go to MedWatch.

To submit your voluntary report: