Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DUEXIS
Product Details
NDC Product Code
75987-010Application Number
NDA022519Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 6, 2021IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
FamotidineActive
Code: 5QZO15J2Z8Class: ACTIBQuantity: 26.6 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT