Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Marksans Pharma Limited
Polygen Pharmaceuticals LLC
925822975
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
NDC Product Code
52605-121Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2011CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Ibuprofen
Product Details
NDC Product Code
52605-122Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2011CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Ibuprofen
Product Details
NDC Product Code
52605-123Application Number
ANDA090796Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2011COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT