MedPath

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

NDC Product Code0270-7350
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-9350
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-7400
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-9400
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-7300
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-9300
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

NDC Product Code0270-7250
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection

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

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Iomeron - FDA Drug Approval Details