GRANISETRON HYDROCHLORIDE
These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993
Approved
Approval ID
a43da9a3-1997-40d9-8622-97490a5c0642
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2011
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
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 Code55648-662
Application NumberANDA078566
Product Classification
M
Marketing Category
C73584
G
Generic Name
GRANISETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 29, 2011
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT