ISOVUE-M
ISOVUE-M 200Iopamidol Injection 41%ISOVUE-M 300Iopamidol Injection 61%
Approved
Approval ID
11e893d2-0183-4581-b908-c8b7302c7edb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2022
Manufacturers
FDA
Bracco Diagnostics Inc
DUNS: 849234661
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IOPAMIDOL
PRODUCT DETAILS
NDC Product Code0270-1412
Application NumberNDA018735
Marketing CategoryC73594
Route of AdministrationINTRATHECAL
Effective DateNovember 3, 2022
Generic NameIOPAMIDOL
INGREDIENTS (3)
IOPAMIDOLActive
Quantity: 612 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB
tromethamineInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
edetate calcium disodiumInactive
Quantity: 0.39 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
IOPAMIDOL
PRODUCT DETAILS
NDC Product Code0270-1411
Application NumberNDA018735
Marketing CategoryC73594
Route of AdministrationINTRATHECAL
Effective DateNovember 3, 2022
Generic NameIOPAMIDOL
INGREDIENTS (3)
IOPAMIDOLActive
Quantity: 408 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB
tromethamineInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
edetate calcium disodiumInactive
Quantity: 0.26 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT