Granisetron Hydrochloride
These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP.GRANISETRON HYDROCHLORIDE injection USP, for intravenous useInitial U.S. Approval: 1993
Approved
Approval ID
02f350c9-b7d2-4906-af28-70ed4461ff23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granisetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-546
Application NumberANDA079078
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 23, 2022
FDA Product Classification
INGREDIENTS (8)
Granisetron HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT