Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GE Healthcare Ireland Limited
GE Healthcare Inc.
988006565
GE Healthcare Shanghai, Co., Ltd.
GE Healthcare Inc.
545292716
GE Healthcare AS
GE Healthcare Inc.
515048908
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Visipaque
Product Details
NDC Product Code
0407-2223Application Number
NDA020351Marketing Category
NDA (C73594)Route of Administration
INTRAVASCULAREffective Date
April 30, 2023calcium chlorideInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.044 mg in 1 mL
IodixanolActive
Code: HW8W27HTXXClass: ACTIRQuantity: 320 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 1.11 mg in 1 mL
tromethamineInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.2 mg in 1 mL
edetate calcium disodiumInactive
Code: 25IH6R4SGFClass: IACTQuantity: 0.1 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Visipaque
Product Details
NDC Product Code
0407-2222Application Number
NDA020351Marketing Category
NDA (C73594)Route of Administration
INTRAVASCULAREffective Date
April 30, 2023IodixanolActive
Code: HW8W27HTXXClass: ACTIRQuantity: 270 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 1.87 mg in 1 mL
calcium chlorideInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.074 mg in 1 mL
edetate calcium disodiumInactive
Code: 25IH6R4SGFClass: IACTQuantity: 0.1 mg in 1 mL
tromethamineInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.2 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT