Ondansetron
These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP ONDANSETRON Injection, USP for intravenous or intramuscular use Initial U.S. Approval: 1991
Approved
Approval ID
bb4bc810-db26-471b-9ce7-6e2fb3018af0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
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 Code0143-9890
Application NumberANDA076781
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (7)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
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
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.25 mg in 1 mL
Code: B22547B95K
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9891
Application NumberANDA076780
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (5)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
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
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.25 mg in 1 mL
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT