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U.S. Department of Health and Human Services

For Industry

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Pharmacologic Class

Pharmacologic Class:
Mechanism of Action (MOA), Physiologic Effect (PE), Chemical Structure (CS),
and FDA Established Pharmacologic Class (EPC)

 

Source: The codes are from the National Drug File Reference Terminology (NDF-RT) maintained by the Department of Veterans Affairs.

 

National Drug File Reference Terminology OID: 2.16.840.1.113883.3.26.1.5

 

The full list of NDF-RT codes can be found on the NCI web site at:  ftp://ftp1.nci.nih.gov/pub/cacore/EVS/NDF-RT/ 

In January 2006, FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products.[1]  The new prescribing information format is intended to make it easier for health care professionals to access, read, and use to make prescribing decisions.

 

The rule requires the following statement to appear under the Indications and Usage section of Highlights if a drug is a member of an established pharmacologic class:[2]

 

“(Drug) is a (established pharmacologic class) indicated for (indication(s)).”

 

The pharmacologic class codes for active moieties in FDA approved human prescription drug products are included in the downloadable .zip file below.   

FDA Pharmacologic Classes

 

 

The list of pharmacologic class indexing terms will be regularly revised to ensure that the most up-to-date information is available to the public.

 

For more information about how FDA determines the established pharmacologic class for a drug product, see:

Guidance for Industry and Review Staff, Labeling for Human Prescription Drugs and Biological Products—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
MAPP 7400.13: Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information

 

 



[1] See 21 CFR parts 201, 314, and 601 Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (71 FR 3922).

 

[2] See 21 CFR 201.57(a)(6).