Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen Childrens
Product Details
NDC Product Code
49035-716Application Number
ANDA074916Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 3, 2025IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 100 mg in 5 mL
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT