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Active ingredient

Irinotecan

29 finished FDA listings contain Irinotecan as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
IRINOTECAN HYDROCHLORIDE
Dosage forms
Injection, Injection, Powder, For Solution, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
15
Strengths listed
100 mg/5ml · 20 mg/ml · 4.3 mg/ml · 40 mg/2ml
Brand names in FDA listings
Camptosar, Onivyde

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 51499

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 020571PFIZER INC1996-06-143
ANDA 078589ACTAVIS TOTOWA2008-02-271
ANDA 077915HOSPIRA2008-02-271
ANDA 077776FRESENIUS KABI USA2008-02-271
ANDA 091032HIKMA FARMACEUTICA2010-12-203
ANDA 090675HENGRUI PHARMA2011-12-161
NDA 207793IPSEN2015-10-221
ANDA 203380QILU PHARM HAINAN2016-05-035
ANDA 206935INGENUS PHARMS LLC2017-05-262
ANDA 212993GLAND2019-11-187
ANDA 213278EUGIA PHARMA2020-11-024

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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