Ibuprofen
IBUPROFEN Tablets USP
Approved
Approval ID
e9a5f214-a387-4429-a875-eb1e9aa714c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2023
Manufacturers
FDA
Quality Care Products LLC
DUNS: 831276758
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
PRODUCT DETAILS
NDC Product Code55700-445
Application NumberANDA091625
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2019
Generic NameIbuprofen
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Ibuprofen
PRODUCT DETAILS
NDC Product Code55700-446
Application NumberANDA091625
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2019
Generic NameIbuprofen
INGREDIENTS (12)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT