Ondansetron
These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
Approved
Approval ID
c0640556-ae39-4b57-9030-03a23dcdb60c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-0591
Application NumberANDA090469
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 30, 2021
Generic NameOndansetron
INGREDIENTS (8)
ONDANSETRONActive
Quantity: 8 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT