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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

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Ondansetron - FDA Drug Approval Details