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Active ingredient

Granisetron

14 finished FDA listings contain Granisetron as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
GRANISETRON, GRANISETRON HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution, Patch, Solution, Tablet, Tablet, Film Coated
Routes
Intravenous, Oral, Subcutaneous, Transdermal
Manufacturers / labelers
10
Strengths listed
.1 mg/ml · 1 mg/1 · 1 mg/ml · 10 mg/.4ml · 2 mg/10ml · 3.1 mg/24h · 4 mg/4ml
Brand names in FDA listings
Granisetron, Granisol, Sancuso, Sustol

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 26237

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 078678ORBION PHARMS2008-02-131
ANDA 078096FRESENIUS KABI USA2008-06-301
NDA 022198APOTEX2008-09-121
ANDA 078969NATCO PHARMA2009-06-222
ANDA 078629HIKMA FARMACEUTICA2009-12-232
ANDA 091137MYLAN ASI2010-04-091
ANDA 091136MYLAN ASI2010-04-092
ANDA 204238EUGIA PHARMA2016-07-062
NDA 022445HERON THERAPS INC2016-08-091
ANDA 219282PHARMOBEDIENT2025-03-171

Official labeling on DailyMed

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