Skip to content
LookupMeds

Active ingredient

Gemcitabine

41 finished FDA listings contain Gemcitabine as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
GEMCITABINE, GEMCITABINE HYDROCHLORIDE
Dosage forms
Injection, Powder, Lyophilized, For Solution, Injection, Solution, System
Routes
Intravenous, Intravesical
Manufacturers / labelers
13
Strengths listed
1 g/1 · 1 g/25ml · 1 g/26.3ml · 100 mg/ml · 2 g/50ml · 2 g/52.6ml · 200 mg/1 · 200 mg/5.26ml · 200 mg/5ml · 225 mg/1 · 38 mg/ml
Brand names in FDA listings
Avgemsi, Gemcitabine, Inlexzo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 12574

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 079183HOSPIRA INC2010-11-151
ANDA 090799FRESENIUS KABI USA2011-05-165
ANDA 091365DR REDDYS LABS LTD2011-07-256
ANDA 078759TEYRO LABS2011-07-252
ANDA 078339HOSPIRA2011-07-252
NDA 200795HOSPIRA INC2011-08-046
ANDA 202485JIANGSU HANSOH PHARM2013-05-072
ANDA 204520GLAND2016-01-052
NDA 209604ACCORD HLTHCARE2017-08-033
ANDA 205242MYLAN LABS LTD2017-12-063
ANDA 209077SAGENT PHARMS INC2018-07-201
ANDA 212129MEITHEAL2020-12-112
ANDA 213175HIKMA2023-03-073
NDA 219920AVYXA HOLDINGS2025-06-272
NDA 219683JANSSEN BIOTECH2025-09-091

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

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