How can I use an online database of drug labels to tell if a drug is FDA-approved?
- FDA Online Label Repository
The FDA Online Label Repository includes labels for both human and animal drugs, but does not contain a complete listing of labels. You can search for a drug’s label using several parameters, such as proprietary name (also known as trade name or brand name), active ingredient, or National Drug Code (NDC) number. When the search results come up, look at the far right column with the header, “Marketing Category,” to tell if the drug is approved.
|If the “Marketing Category” column says:||Meaning:||Then the drug is:|
|NDA||New Drug Application||An FDA-approved human drug|
|ANDA||Abbreviated New Drug Application||An FDA-approved generic human drug|
|BLA||Biologics License Application||An FDA-approved human therapeutic biologic produc|
|NADA||New Animal Drug Application||An FDA-approved animal drug|
|ANADA||Abbreviated New Animal Drug Application||An FDA-approved generic animal drug|
|Conditional NADA||Conditional New Animal Drug Application||An FDA-conditionally-approved animal drug for a minor species or a minor use in a major species|
|Legally Marketed Unapproved New Animal Drugs for Minor Species||FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species||A legally marketed unapproved product for a non-food-producing minor species or an early life stage of a food-producing minor species|
|Unapproved Drug Other;|
Unapproved Medical Gas; or
|No application||Not approved by FDA|
*Note: This table doesn’t include all marketing categories for human drugs, such as over-the-counter drugs for people that are marketed under a drug monograph. For definitions of all marketing categories, see Marketing Category.
If the drug is an approved human or animal drug, a conditionally approved animal drug, or an approved human therapeutic biologic product, the six-digit application number is listed in the column with the header, “Application Number or Regulatory Citation.” The six-digit Minor species Index File (MIF) number is listed in this column if the drug is an FDA indexed animal drug. The column is blank for an unapproved drug.
Click on a specific drug listed in the search results to view the label information. An unapproved drug has disclaimer statements at the top of the label, indicating that FDA has not reviewed the safety or effectiveness of the product or approved the product's labeling.
For each drug in the repository, there is a “Marketing Information” box beneath the label. This box contains the marketing category of the drug. For an approved human or animal drug, conditionally approved animal drug, or approved human therapeutic biologic product, this box also contains the application number. The MIF number is listed in this box if the drug is an FDA indexed animal drug. The box is blank for an unapproved drug.
DailyMed, a website run by the National Library of Medicine, includes labels for marketed human and animal drugs, but does not contain a complete listing of labels. Using DailyMed, you can search for a drug’s label by drug name (proprietary name or established name) or National Drug Code (NDC) number. When the search results come up, click on a specific drug to view the label information. The “Marketing Status” box on the top right contains similar information to the “Marketing Category” column described above for the FDA Online Label Repository. This information will tell you if the drug is approved.
To differentiate animal drugs from human drugs, DailyMed identifies animal drugs, both approved and unapproved, by the header, “Veterinary Medicine Labels,” at the top of the page.
What is a drug’s “proprietary name” versus its “established name”?
A drug’s “proprietary name” is chosen by the drug company and is the name the company uses to market the drug. The proprietary name is also called the drug’s trade name or brand name. A drug’s “established name” is the drug’s active ingredient. The established name is also called the drug’s generic name. Please note that a generic name is not the same as a generic drug. A generic drug is an FDA-approved copy of a brand name drug.
Here are a few examples to help you keep the types of names straight:
|Trade Name||Proprietary Name||Established Name||Active Ingredient||Generic Name|
|Heartgard® TabletsB||Heartgard® Tablets||ivermectin||ivermectin||ivermectin|
|Iverhart™ TabletsC||Iverhart™ Tablets||ivermectin||ivermectin||ivermectin|
|AFlea product for dogs marketed by Elanco Animal Health, A Division of Eli Lilly & Co. under NADA 141-277.|
BHeartworm preventive for dogs marketed by Merial Ltd. under NADA 138-412.
CHeartworm preventive for dogs marketed by Virbac AH, Inc. under ANADA 200-270. Iverhart™ Tablets are a generic copy of Heartgard® Tablets.