ONDANSETRON HYDROCHLORIDE
PRESCRIBING INFORMATION ONDANSETRON INJECTION USP
Approved
Approval ID
bf5cbf1b-af47-419e-bc32-6d6b94a785b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2011
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-726
Application NumberANDA077716
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 29, 2011
FDA Product Classification
INGREDIENTS (5)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ONDANSETRON HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-727
Application NumberANDA077577
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 29, 2011
FDA Product Classification
INGREDIENTS (7)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT