Is Febuxostat FDA approved?

Febuxostat holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Febuxostat make?

1 product is listed under Febuxostat in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Febuxostat

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 0
Countries: 0

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Marketed products

Brand	Generic name	Form / route	NDC
-	Febuxostat	powder	70966-0041BULK INGREDIENT

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Other companies listing febuxostat

Dr. Reddy's Laboratories Limited15 sites · 683 NDC
Sun Pharmaceutical Industries Limited13 sites · 918 NDC
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Indoco Remedies Limited7 sites · 58 NDC
Aurobindo Pharma Limited6 sites · 1,453 NDC
Pharma Packaging Solutions, LLC dba Tjoapack, LLC5 sites · 667 NDC
Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
Zhejiang Huahai Pharmaceutical Technology Co Ltd3 sites · 76 NDC
YiChang HEC ChangJiang Pharmaceutical Co., Ltd.2 sites · 8 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC

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Common questions

Is Febuxostat FDA approved?: Febuxostat holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Febuxostat make?: 1 product is listed under Febuxostat in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.