Iomeron
Approved
Approval ID
30a993a8-9afb-42c2-a4b2-72a6b361d43c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
BIPSO GmbH
DUNS: 342104149
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 Code76381-725
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IOMEPROLActive
Quantity: 510 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
Iomeprol Injection
PRODUCT DETAILS
NDC Product Code76381-730
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
PRODUCT DETAILS
NDC Product Code76381-935
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 Code76381-930
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
PRODUCT DETAILS
NDC Product Code76381-740
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 Code76381-940
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVASCULAR
Effective DateJuly 21, 2022
Generic NameIomeprol Injection
INGREDIENTS (4)
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
IOMEPROLActive
Quantity: 816 mg in 1 mL
Code: 17E17JBP8L
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iomeprol Injection
PRODUCT DETAILS
NDC Product Code76381-735
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