ISOVUE
ISOVUE Imaging Bulk Package For use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. ISOVUE-300Iopamidol Injection 61% ISOVUE-370Iopamidol Injection 76%
Approved
Approval ID
797a11d7-dcd4-43ff-311b-3b48a10da2f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2023
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 Code0270-1315
Application NumberNDA020327
Product Classification
M
Marketing Category
C73594
G
Generic Name
IOPAMIDOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 2, 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 Code0270-1316
Application NumberNDA020327
Product Classification
M
Marketing Category
C73594
G
Generic Name
IOPAMIDOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 2, 2022
FDA Product Classification
INGREDIENTS (3)
IOPAMIDOLActive
Quantity: 755 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB
TROMETHAMINEInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.48 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT