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
988006565
GE Healthcare Lindesnes
GE Healthcare
518890970
GE Healthcare Shanghai Co., Ltd.
GE Healthcare
545292716
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omnipaque
Product Details
NDC Product Code
0407-1413Application Number
NDA020608Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 30, 2023IohexolActive
Code: 4419T9MX03Class: ACTIRQuantity: 300 mg in 1 mL
edetate calcium disodiumInactive
Code: 25IH6R4SGFClass: IACTQuantity: 0.1 mg in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
tromethamineInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.21 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
Omnipaque
Product Details
NDC Product Code
0407-1414Application Number
NDA020608Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 30, 2023tromethamineInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.21 mg in 1 mL
IohexolActive
Code: 4419T9MX03Class: ACTIRQuantity: 350 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