Ibuprofen
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
Approved
Approval ID
faebc392-0fd9-4c71-8471-beba10dda022
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
PRODUCT DETAILS
NDC Product Code53746-464
Application NumberANDA078558
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 31, 2023
Generic NameIbuprofen
INGREDIENTS (1)
IBUPROFENActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
Ibuprofen
PRODUCT DETAILS
NDC Product Code53746-466
Application NumberANDA078558
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 31, 2023
Generic NameIbuprofen
INGREDIENTS (1)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
Ibuprofen
PRODUCT DETAILS
NDC Product Code53746-465
Application NumberANDA078558
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 31, 2023
Generic NameIbuprofen
INGREDIENTS (1)
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB