Ondansetron
Ondansetron ODT 4mg Tablets
Approved
Approval ID
af836a30-5e51-5c97-e053-2995a90a15b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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 Code80425-0073
Application NumberANDA090469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (1)
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB