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Ultravist

These highlights do not include all the information needed to use ULTRAVIST Injection safely and effectively. See full prescribing information for ULTRAVIST Injection.ULTRAVIST (iopromide) Injection, for intravenous or intra-arterial useInitial U.S. Approval: 1995

Approved
Approval ID

df917c3a-59a2-4ed1-8470-8a5394c73325

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 21, 2023

Manufacturers
FDA

Bayer HealthCare Pharmaceuticals Inc.

DUNS: 005436809

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

iopromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50419-347
Application NumberNDA020220
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRAVENOUS, INTRA-ARTERIAL
Effective DateMay 21, 2023
FDA Product Classification

INGREDIENTS (5)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOPROMIDEActive
Quantity: 300 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT

iopromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50419-348
Application NumberNDA020220
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateMay 21, 2023
FDA Product Classification

INGREDIENTS (5)

IOPROMIDEActive
Quantity: 370 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

iopromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50419-346
Application NumberNDA020220
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRAVENOUS, INTRA-ARTERIAL
Effective DateMay 21, 2023
FDA Product Classification

INGREDIENTS (5)

EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
IOPROMIDEActive
Quantity: 370 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

iopromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50419-342
Application NumberNDA020220
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRAVENOUS, INTRA-ARTERIAL
Effective DateMay 21, 2023
FDA Product Classification

INGREDIENTS (5)

IOPROMIDEActive
Quantity: 240 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

iopromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50419-344
Application NumberNDA020220
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRAVENOUS, INTRA-ARTERIAL
Effective DateMay 21, 2023
FDA Product Classification

INGREDIENTS (5)

IOPROMIDEActive
Quantity: 300 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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Ultravist - FDA Drug Approval Details