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CSMS # 61329923 - Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Class Code and Product Codes

The Food and Drug Administration (FDA) has created new Center for Drug Evaluation and Research (CDER) class and product codes listed below. The product codes are available immediately, and should be used for all homeopathic drugs. The product code/description with the drug class that most closely characterizes the product should be selected when coding homeopathic drugs. For more information on drug product codes, refer to the FDA Product Code Builder Tutorial. For assistance with product code identification, refer to the FDA Product Code Builder.

Class Code/Description

66X/Homeopathic Drugs

Product Code/Description

66X[][]01/Homeopathic Analgesic

66X[][]02/Homeopathic Allergy

66X[][]03/Homeopathic Anti-Infective

66X[][]04/Homeopathic Dermatological

66X[][]05/Homeopathic Gastrointestinal

66X[][]06/Homeopathic Respiratory

66X[][]07/Homeopathic Multiple Indications

66X[][]99/Homeopathic N.E.C.

Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov.

For assistance with product code identification, the public may also refer to the FDA Product Code Builder.