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Active ingredient

Febuxostat

45 finished FDA listings contain Febuxostat as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FEBUXOSTAT
Dosage forms
Film, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
24
Strengths listed
40 mg/1 · 80 mg/1
Brand names in FDA listings
Febuxostat, Uloric

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 73689

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021856TAKEDA PHARMS USA2009-02-132
ANDA 205421ALEMBIC2019-07-014
ANDA 205467SUN PHARM2019-07-016
ANDA 205414HIKMA2019-10-155
ANDA 210292REGCON HOLDINGS2019-12-302
ANDA 210461MSN2019-12-306
ANDA 213069SUNSHINE2020-06-024
ANDA 205374DR REDDYS2020-10-222
ANDA 212924ALKEM LABS LTD2021-12-072
ANDA 206266PRINSTON INC2022-03-282
ANDA 205443ZYDUS LIFESCIENCES2023-01-096
ANDA 207293MACLEODS PHARMS2023-09-282
ANDA 210741AUROBINDO PHARMA LTD2023-10-252

Official labeling on DailyMed

Showing the 12 most recent of 26 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.