Ibuprofen
Ibuprofen Tablets, USP
Approved
Approval ID
366536da-fb9a-4ed1-84db-10d69d9247f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-076
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2011
FDA Product Classification
INGREDIENTS (1)
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-077
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2011
FDA Product Classification
INGREDIENTS (1)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB