Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iodixanol
Product Details
NDC Product Code
65219-383Application Number
ANDA214271Marketing Category
ANDA (C73584)Route of Administration
INTRAVASCULAREffective Date
May 31, 2022SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 1.11 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.044 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.2 mg in 1 mL
IodixanolActive
Code: HW8W27HTXXClass: ACTIRQuantity: 320 mg in 1 mL
Iodixanol
Product Details
NDC Product Code
65219-381Application Number
ANDA214271Marketing Category
ANDA (C73584)Route of Administration
INTRAVASCULAREffective Date
May 31, 2022CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.074 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 1.87 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACTQuantity: 0.1 mg in 1 mL
IodixanolActive
Code: HW8W27HTXXClass: ACTIRQuantity: 270 mg in 1 mL