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Active ingredient

Azacitidine

28 finished FDA listings contain Azacitidine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AZACITIDINE
Dosage forms
Injection, Powder, Lyophilized, For Solution, Tablet, Film Coated
Routes
Intravenous, Oral, Subcutaneous
Manufacturers / labelers
21
Strengths listed
100 mg/1 · 100 mg/30ml · 100 mg/4ml · 100 mg/50ml · 200 mg/1 · 300 mg/1
Brand names in FDA listings
Azacitidine, Azacitidine Azacitidine, Onureg, Vidaza

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1251

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 050794BRISTOL-MYERS2004-05-191
ANDA 201537DR REDDYS2013-09-165
NDA 208216ACTAVIS LLC2016-04-291
ANDA 207518ADAPTIS2016-09-294
ANDA 207234NATCO PHARMA LTD2017-06-231
ANDA 207475ACCORD HLTHCARE2018-07-022
ANDA 209337EUROHLTH INTL SARL2020-06-081
NDA 214120BRISTOL2020-09-012
ANDA 212128MEITHEAL2020-11-022
ANDA 211549AMNEAL2022-02-031
ANDA 215066EUGIA PHARMA2022-12-301
ANDA 215905JIANGSU HANSOH PHARM2023-06-281
ANDA 212580MSN LABS PVT LTD2024-05-163
ANDA 215765HETERO LABS LTD VI2024-10-151
ANDA 217453RELIANCE LIFE2025-05-202

Official labeling on DailyMed

Showing the 12 most recent of 27 labels.

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