ONDANSETRON
These highlights do not include all the information needed to use ONDANSETRON INJECTION safely and effectively. See full prescribing information for ONDANSETRON INJECTION. ONDANSETRON injection, for intravenous or intramuscular use Initial U.S. Approval: 1991
Approved
Approval ID
b746d4db-43e6-4219-9e6b-f53e59581305
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-549
Application NumberANDA090648
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (6)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.5 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.2 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATEInactive
Quantity: 0.25 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
ONDANSETRON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-547
Application NumberANDA079224
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (4)
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.5 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9.0 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
SODIUM CITRATEInactive
Quantity: 0.25 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT