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Active ingredient

Allopurinol

169 finished FDA listings contain Allopurinol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ALLOPURINOL, ALLOPURINOL SODIUM
Dosage forms
Injection, Powder, Lyophilized, For Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
47
Strengths listed
100 mg/1 · 200 mg/1 · 300 mg/1 · 500 mg/25ml
Brand names in FDA listings
Aloprim

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 519

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 016084CASPER PHARMA LLC1966-08-194
NDA 018832WATSON LABS1984-09-282
NDA 018877WATSON LABS1984-09-284
ANDA 018659MYLAN1986-10-2416
ANDA 071450SUN PHARM INDUSTRIES1987-01-0913
ANDA 071587DR REDDYS1987-04-024
NDA 020298MYLAN1996-05-171
ANDA 075798PH HEALTH2003-06-2712
ANDA 076870HIKMA2004-08-261
ANDA 077353CHARTWELL2005-09-082
ANDA 203154ACCORD HLTHCARE2013-05-0611
ANDA 204467REGCON HOLDINGS2016-07-2833
ANDA 210117ZYDUS PHARMS2017-10-128
ANDA 211820UNICHEM2019-03-1216
ANDA 212363GLAND2022-01-262
ANDA 214443HARMAN FINOCHEM2022-03-0713
ANDA 217748HETERO LABS LTD V2023-08-0320
ANDA 215091AUROBINDO PHARMA LTD2025-04-144

Official labeling on DailyMed

Showing the 12 most recent of 134 labels.

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