FDA.reportPublic FDA data

Ultravist

Product NDC
50419-348
11-digit product format
504190348
Labeler code
50419
Product ID
50419-348_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
370 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
IOPROMIDE370 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
50419-348-052024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-102024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-112024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-122024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-132024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-202024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-212024-08-21C16284748780-11030e365-08f6-111a-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
50419-348-052024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-102024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-112024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-122024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-132024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-202024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-212024-07-30C16284748780-11030e365-08f6-111a-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
50419-348-052024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-102024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-112024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-122024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-132024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-202024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-212024-01-30C16284748780-11030e365-08f6-111a-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
50419-348-05Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-348-05Ultravist10 in 1 CARTONINJECTION1025
50419-348-10Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-348-11Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-348-12Ultravist10 in 1 CARTONINJECTION1025
50419-348-12Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-348-13Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-348-13Ultravist10 in 1 CARTONINJECTION1025
50419-348-20Ultravist200 mL in 1 VIAL, GLASSINJECTION20025
50419-348-21Ultravist200 mL in 1 VIAL, GLASSINJECTION20025
50419-348-21Ultravist10 in 1 CARTONINJECTION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-348-05ML - Milliliter50419-3480ffc4970-480b-4160-85f5-d409156a0b7a12022-07-06
50419-348-10ML - Milliliter50419-34890b0046f-6634-48ca-9fde-75924f041c7f12022-07-06
50419-348-11ML - Milliliter50419-3483206cc66-cdd6-45f9-8c72-824764f9e7b612022-07-06
50419-348-12ML - Milliliter50419-348b3b2b6c9-69a3-4c65-8381-ae02bd1f060412022-07-06
50419-348-13ML - Milliliter50419-348a3cd2048-eb27-4374-b1a2-049f3078a7a712022-07-06
50419-348-20ML - Milliliter50419-3481101898b-512d-418d-9c80-27d78658017812022-07-06
50419-348-21ML - Milliliter50419-3481fd459ed-f9cb-4c09-9c46-430ed690886612022-07-06

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
50419-348ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 11 package rows20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-348-055041903480510 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS2022-06-080000-00-00NoNoCurrent
50419-348-1050419034810100 mL in 1 VIAL, GLASS (50419-348-10) 100 ml2022-06-080000-00-00NoNoCurrent
50419-348-1150419034811100 mL in 1 VIAL, GLASS (50419-348-11) 100 ml2022-06-080000-00-00NoNoCurrent
50419-348-125041903481210 VIAL, GLASS in 1 CARTON (50419-348-12) / 100 mL in 1 VIAL, GLASS2022-06-080000-00-00NoNoCurrent
50419-348-135041903481310 VIAL, GLASS in 1 CARTON (50419-348-13) / 100 mL in 1 VIAL, GLASS2022-06-080000-00-00NoNoCurrent
50419-348-2050419034820200 mL in 1 VIAL, GLASS (50419-348-20) 200 ml2022-06-080000-00-00NoNoCurrent
50419-348-215041903482110 VIAL, GLASS in 1 CARTON (50419-348-21) / 200 mL in 1 VIAL, GLASS2022-06-080000-00-00NoNoCurrent