Ondansetron
These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON. ONDANSETRON injection, USP for intravenous or intramuscular use Initial U.S. Approval: 2006
Approved
Approval ID
849ebb76-89cd-55a4-e053-2991aa0a4ff5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON
PRODUCT DETAILS
NDC Product Code68071-4810
Application NumberANDA077548
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateFebruary 17, 2021
Generic NameONDANSETRON
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.46 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.25 mg in 1 mL
Code: B22547B95K
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT