Omnipaque
OMNIPAQUE™ (iohexol) Injection 300 350
Approved
Approval ID
442aed6e-6242-4a96-90aa-d988b62d55e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2023
Manufacturers
FDA
GE Healthcare Inc.
DUNS: 053046579
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iohexol
PRODUCT DETAILS
NDC Product Code0407-1414
Application NumberNDA020608
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAVASCULAR, ORAL, RECTAL
Effective DateMay 8, 2023
Generic NameIohexol
INGREDIENTS (5)
IohexolActive
Quantity: 350 mg in 1 mL
Code: 4419T9MX03
Classification: ACTIR
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
TromethamineInactive
Quantity: 1.21 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
Edetate calcium disodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Iohexol
PRODUCT DETAILS
NDC Product Code0407-1413
Application NumberNDA020608
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTAL
Effective DateMay 8, 2023
Generic NameIohexol
INGREDIENTS (5)
IohexolActive
Quantity: 300 mg in 1 mL
Code: 4419T9MX03
Classification: ACTIR
TromethamineInactive
Quantity: 1.21 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Edetate calcium disodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT