Ibuprofen
IBUPROFEN TABLETS, USP
Approved
Approval ID
8df77ead-27eb-4f6f-95a9-f68d3e9cfa71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code53746-132
Application NumberANDA071335
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (13)
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT