Ibuprofen
Ibuprofen Tablets, USP
Approved
Approval ID
912c536b-0d0c-4a9f-8778-c1534ceca658
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2012
Manufacturers
FDA
Med Health Pharma, LLC
DUNS: 962603812
Products 1
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 Code51138-039
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (1)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB