Ibuprofen
Ibuprofen Tablets, USP
Approved
Approval ID
8a187e32-4db8-4cd2-b619-f97c9b312d5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 3
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 Code66336-430
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2013
FDA Product Classification
INGREDIENTS (1)
IBUPROFENActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66336-556
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2013
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 Code66336-030
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2013
FDA Product Classification
INGREDIENTS (1)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB