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Active ingredient

Doxorubicin

64 finished FDA listings contain Doxorubicin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DOXORUBICIN, DOXORUBICIN HYDROCHLORIDE
Dosage forms
Injectable, Liposomal, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Injection, Suspension, Liposomal
Routes
Intravenous, Intravitreal
Manufacturers / labelers
19
Strengths listed
2 mg/ml
Brand names in FDA listings
Doxil, Doxorubicin Hydrochloride, Doxorubicin Hydrochloride Liposome, Doxorubicin Hydrochloride, Liposomal

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3639

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 050629PFIZER1987-12-2310
ANDA 062921HIKMA1989-03-172
ANDA 062975HIKMA1989-03-176
ANDA 064097HIKMA1994-09-132
ANDA 063277FRESENIUS KABI USA1995-10-262
NDA 050718BAXTER HLTHCARE CORP1995-11-176
ANDA 200170MYLAN LABS LTD2011-10-281
ANDA 091418SUN PHARM INDS2012-02-152
ANDA 203263SUN PHARM2013-02-046
ANDA 203622ACTAVIS INC2014-06-271
ANDA 208888AMNEAL2017-02-172
ANDA 208657DR REDDYS2017-05-151
ANDA 209825GLAND2017-08-114
ANDA 212299ZYDUS LIFESCIENCES2020-09-106
ANDA 215178LUPIN2024-07-163
ANDA 219199ALEMBIC2025-06-278
ANDA 219881QILU PHARM HAINAN2026-02-031

Official labeling on DailyMed

Showing the 12 most recent of 30 labels.

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