Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GE Healthcare Lindesnes
GE Healthcare Inc.
518890970
GE Healthcare Ireland Limited
GE Healthcare Inc.
988006565
GE Healthcare Shanghai Co., Ltd.
GE Healthcare Inc.
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
0407-1414Application Number
NDA020608Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, INTRAVASCULAR, ORAL, RECTALEffective Date
April 25, 2023TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
IohexolActive
Code: 4419T9MX03Class: ACTIRQuantity: 350 mg in 1 mL
Omnipaque
Product Details
NDC Product Code
0407-1413Application Number
NDA020608Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTALEffective Date
April 25, 2023HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
IohexolActive
Code: 4419T9MX03Class: ACTIRQuantity: 300 mg in 1 mL