Ultravist
These highlights do not include all the information needed to use ULTRAVIST IMAGING BULK PACKAGE safely and effectively. See full prescribing information for ULTRAVIST IMAGING BULK PACKAGE.ULTRAVIST (iopromide) injection, for intravenous useInitial U.S. Approval: 1995
Approved
Approval ID
65647318-27e4-4f37-bd68-50eea52d6c5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 2
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 Code50419-346
Application NumberNDA021425
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRA-ARTERIAL
Effective DateAugust 1, 2019
FDA Product Classification
INGREDIENTS (5)
IOPROMIDEActive
Quantity: 370 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
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 NumberNDA021425
Product Classification
M
Marketing Category
C73594
G
Generic Name
iopromide
Product Specifications
Route of AdministrationINTRA-ARTERIAL
Effective DateAugust 1, 2019
FDA Product Classification
INGREDIENTS (5)
IOPROMIDEActive
Quantity: 300 mg in 1 mL
Code: 712BAC33MZ
Classification: ACTIR
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT