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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, for intravenous useInitial U.S. Approval: 1993

Approved
Approval ID

8d88adba-7f5e-4e97-84b3-6ca8ec98c023

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2017

Manufacturers
FDA

Mylan Institutional LLC

DUNS: 790384502

Products 3

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 Code67457-864
Application NumberANDA091137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2017
FDA Product Classification

INGREDIENTS (5)

GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Granisetron Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67457-863
Application NumberANDA091136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2017
FDA Product Classification

INGREDIENTS (5)

GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Granisetron Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67457-861
Application NumberANDA091136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granisetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2017
FDA Product Classification

INGREDIENTS (5)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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Granisetron Hydrochloride - FDA Drug Approval Details