Ondansetron
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
Approved
Approval ID
7f60016c-7c84-4ffa-8adb-2688105b3054
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2021
Manufacturers
FDA
Lohxa
DUNS: 079872715
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 Code70166-486
Application NumberANDA091483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 5 mL
Code: NMH84OZK2B
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT