Ondansetron
ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets 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. Initial U.S. Approval: 1991
Approved
Approval ID
352de988-d166-c2d8-e063-6294a90acc01
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2025
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
PRODUCT DETAILS
NDC Product Code42291-457
Application NumberANDA078152
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameOndansetron
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
Ondansetron
PRODUCT DETAILS
NDC Product Code42291-458
Application NumberANDA078152
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameOndansetron
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ONDANSETRONActive
Quantity: 8 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB