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Active ingredient

Cytarabine

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

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FDA NDC Directory

Ingredient names as written by FDA
CYTARABINE
Dosage forms
Injection, Solution
Routes
Intrathecal, Intravenous, Subcutaneous
Manufacturers / labelers
5
Strengths listed
100 mg/ml · 2 g/20ml · 20 mg/ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3041

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 071868HOSPIRA1990-06-041
ANDA 072168HOSPIRA1990-08-311
ANDA 072945HOSPIRA1994-02-281
ANDA 075383HOSPIRA1999-11-222
ANDA 076512FRESENIUS KABI USA2004-01-151
ANDA 206190MEITHEAL2017-11-091
ANDA 205696MEITHEAL2018-07-171
ANDA 211937GLAND2019-12-232
ANDA 211938GLAND2019-12-232
ANDA 206189MEITHEAL2020-06-261
ANDA 208485MEITHEAL2022-02-281

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

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