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 use Initial U.S. Approval: 1993
Approved
Approval ID
e07862df-f324-4575-a1ef-f7e1cbab4c7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9744
Application NumberANDA078629
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Granisetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9745
Application NumberANDA078629
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (7)
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT