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 useInitial U.S. Approval: 1991
Approved
Approval ID
5e09e262-dadf-4ae0-825e-448ea8dac174
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2022
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
Products 1
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 Code67184-0507
Application NumberANDA203711
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 2, 2022
FDA Product Classification
INGREDIENTS (5)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT