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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-1412
Application NumberNDA018735
Product Classification
M
Marketing Category
C73594
G
Generic Name
IOPAMIDOL
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateNovember 3, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-1411
Application NumberNDA018735
Product Classification
M
Marketing Category
C73594
G
Generic Name
IOPAMIDOL
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateNovember 3, 2022
FDA Product Classification
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