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Active ingredient

Azathioprine

34 finished FDA listings contain Azathioprine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AZATHIOPRINE, AZATHIOPRINE SODIUM
Dosage forms
Injection, Powder, Lyophilized, For Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
19
Strengths listed
100 mg/1 · 100 mg/10ml · 25 mg/1 · 50 mg/1 · 75 mg/1
Brand names in FDA listings
Azasan, Imuran

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1256

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 016324LEGACY1968-03-202
ANDA 074419HIKMA1995-03-311
ANDA 074069AMNEAL1996-02-168
ANDA 075252AAIPHARMA LLC1999-06-076
ANDA 075568RISING1999-12-131
ANDA 077621ZYDUS PHARMS USA2007-03-1510
ANDA 208687ALKEM LABS LTD2020-03-276

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

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