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Granisetron

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 Use Initial U.S. Approval: 1993 Rx only

Approved
Approval ID

dddc8714-383f-4bc5-a468-ae89dbc802b4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2022

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

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 Code63323-317
Application NumberANDA078522
Product Classification
M
Marketing Category
C73584
G
Generic Name
GRANISETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Quantity: 2.12 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.67 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM

GRANISETRON HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-319
Application NumberANDA078090
Product Classification
M
Marketing Category
C73584
G
Generic Name
GRANISETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.67 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 2.12 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM

GRANISETRON HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-318
Application NumberANDA078096
Product Classification
M
Marketing Category
C73584
G
Generic Name
GRANISETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification

INGREDIENTS (4)

CITRIC ACID MONOHYDRATEInactive
Quantity: 0.67 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Quantity: 2.12 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
GRANISETRON HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 318F6L70J8
Classification: ACTIM

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Granisetron - FDA Drug Approval Details