Skip to content
LookupMeds

Active ingredient

Decitabine

22 finished FDA listings contain Decitabine as their only active ingredient; 1 combination products also contain it.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
DECITABINE, DECITABINE MONOHYDRATE
Dosage forms
Injection, Powder, Lyophilized, For Solution
Routes
Intravenous
Manufacturers / labelers
17
Strengths listed
50 mg/1 · 50 mg/10ml · 50 mg/20ml · 50 mg/26ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 15657

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
ANDA 203131DR REDDYS2013-07-112
ANDA 203475ACCORD HLTHCARE2017-02-271
ANDA 204607PHARMASCIENCE INC2017-05-311
ANDA 206033CHEMI SPA2017-09-221
ANDA 212265MSN2019-08-285
ANDA 210984INGENUS PHARMS LLC2019-09-161
ANDA 205539GLAND2020-11-231
ANDA 212117NIVAGEN2020-12-071
ANDA 212826QILU PHARM HAINAN2021-04-123
ANDA 212959MEITHEAL2021-07-022
ANDA 214569EUGIA PHARMA2021-09-201
ANDA 213472JIANGSU HANSOH PHARM2022-04-151
ANDA 215355HETERO LABS LTD VI2024-05-102

Official labeling on DailyMed

Showing the 12 most recent of 22 labels.

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