Ondansetron
insert
Approved
Approval ID
5e2dbda9-aceb-4bfb-9c3f-e7b6118f580c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
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 Code16590-545
Application NumberANDA078152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (1)
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB