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, USP for intravenous or intramuscular use Initial U.S. Approval: 1991
Approved
Approval ID
e3f22b7e-b6ad-4799-93c7-d30540cada85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Fosun Pharma USA Inc.
DUNS: 080920998
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
PRODUCT DETAILS
NDC Product Code72266-124
Application NumberANDA090648
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 31, 2023
Generic NameOndansetron
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 8.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.5 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 0.25 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.15 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.2 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
Ondansetron
PRODUCT DETAILS
NDC Product Code72266-123
Application NumberANDA079224
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 31, 2023
Generic NameOndansetron
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.5 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 0.25 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM