Ondansetron
These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral useONDANSETRON orally disintegrating tabletsInitial U.S. Approval: 1991
Approved
Approval ID
92a8467d-aece-45ae-b8c8-21988901ba5f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-0134
Application NumberANDA078152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2016
FDA Product Classification
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT