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
af68579f-c863-4535-94af-a4126b43c182
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 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 Code55648-661
Application NumberANDA078565
Product Classification
M
Marketing Category
C73584
G
Generic Name
GRANISETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 29, 2011
FDA Product Classification
INGREDIENTS (8)
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT