FDA.reportPublic FDA data

Ultravist

Product NDC
50419-347
11-digit product format
504190347
Labeler code
50419
Product ID
50419-347_4314fa34-edbc-44f3-b40b-277c6fbd2ab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
iopromide
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA020220
Marketing category
NDA
Marketing start
2022-06-08
Substance
IOPROMIDE
Active strength
300 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultravist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOPROMIDE300 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii712BAC33MZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-347-052024-08-21C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995
50419-347-202024-08-21C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995
50419-347-052024-07-30C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995
50419-347-202024-07-30C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995
50419-347-052024-01-30C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995
50419-347-202024-01-30C16284748780-11030e365-08f6-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-347-05Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-347-20Ultravist200 mL in 1 VIAL, GLASSINJECTION20025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-347-05ML - Milliliter50419-3473daba04c-853e-45b8-8bd0-0b69cf1c103c12022-07-06
50419-347-20ML - Milliliter50419-347e1236129-e4fb-4c69-a20d-d8db9b17d6df12022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOPROMIDEACTIVE INGREDIENT712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
IOPROMIDEACTIVE MOIETY712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-347ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 2 package rows20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-347-055041903470550 mL in 1 VIAL, GLASS (50419-347-05) 50 ml2022-06-080000-00-00NoNoCurrent
50419-347-2050419034720200 mL in 1 VIAL, GLASS (50419-347-20) 200 ml2022-06-080000-00-00NoNoCurrent