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
a0ba2015-66cd-4c85-825f-e5db642ef95f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-382
Application NumberANDA090469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2018
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT