ibuprofen

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

59779-897

Application Number

ANDA074937

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 29, 2025

Ingredients

Code: WK2XYI10QMClass: ACTIBQuantity: 100 mg in 5 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

HIGH FRUCTOSE CORN SYRUPInactive

Code: XY6UN3QB6SClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOL SOLUTIONInactive

Code: 8KW3E207O2Class: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT