Iomeron
Approved
Approval ID
4b31d479-fd1c-5ed7-5bdf-dfd34fe08d98
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
BRACCO DIAGNOSTICS INC
DUNS: 849234661
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7350
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOMEPROLActive
Quantity: 714 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-9350
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 714 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7400
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 816 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-9400
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 816 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7300
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 612 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-9300
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 612 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Iomeprol Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-7250
Product Classification
G
Generic Name
Iomeprol Injection
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
FDA Product Classification
INGREDIENTS (4)
IOMEPROLActive
Quantity: 510 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT