FDA.reportPublic FDA data

Ultravist

Product NDC
50419-346
11-digit product format
504190346
Labeler code
50419
Product ID
50419-346_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
2009-12-30
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
50419-346-052024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-072024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-102024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-122024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-152024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-202024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-262024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-282024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-412024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-432024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-452024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-582024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-652024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-912024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-972024-08-21C16284748780-11030e365-08f6-111a-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
50419-346-052024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-072024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-102024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-122024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-152024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-202024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-262024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-282024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-412024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-432024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-452024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-582024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-652024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-912024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-972024-07-30C16284748780-11030e365-08f6-111a-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
50419-346-052024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-072024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-102024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-122024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-152024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-202024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-262024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-282024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-412024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-432024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-452024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-582024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-652024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-912024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-972024-01-30C16284748780-11030e365-08f6-111a-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
50419-346-05Ultravist10 in 1 CARTONINJECTION1025
50419-346-05Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-346-07Ultravist75 mL in 1 VIAL, GLASSINJECTION7525
50419-346-07Ultravist10 in 1 CARTONINJECTION1025
50419-346-10Ultravist10 in 1 CARTONINJECTION1025
50419-346-10Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-346-12Ultravist10 in 1 CARTONINJECTION1025
50419-346-12Ultravist125 mL in 1 VIAL, GLASSINJECTION12525
50419-346-15Ultravist10 in 1 CARTONINJECTION1025
50419-346-15Ultravist150 mL in 1 VIAL, GLASSINJECTION15025
50419-346-20Ultravist10 in 1 CARTONINJECTION1025
50419-346-20Ultravist200 mL in 1 VIAL, GLASSINJECTION20025
50419-346-26Ultravist10 in 1 PACKAGEINJECTION1025
50419-346-28Ultravist200 mL in 1 BOTTLEINJECTION20025
50419-346-28Ultravist10 in 1 PACKAGEINJECTION1025
50419-346-32Ultravist200 mL in 1 BOTTLEINJECTION20025
50419-346-33Ultravist500 mL in 1 BOTTLEINJECTION50025
50419-346-41Ultravist50 mL in 1 VIAL, GLASSINJECTION5025
50419-346-41Ultravist10 in 1 CARTONINJECTION1025
50419-346-43Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-346-43Ultravist10 in 1 CARTONINJECTION1025
50419-346-45Ultravist150 mL in 1 VIAL, GLASSINJECTION15025
50419-346-45Ultravist10 in 1 CARTONINJECTION1025
50419-346-58Ultravist8 in 1 PACKAGEINJECTION825
50419-346-65Ultravist8 in 1 PACKAGEINJECTION825
50419-346-65Ultravist500 mL in 1 BOTTLEINJECTION50025
50419-346-91Ultravist100 mL in 1 VIAL, GLASSINJECTION10025
50419-346-91Ultravist10 in 1 CARTONINJECTION1025
50419-346-97Ultravist8 in 1 PACKAGEINJECTION825
50419-346-97Ultravist500 mL in 1 BOTTLEINJECTION50025
50419-346-26Ultravist10 in 1 PACKAGEINJECTION1022
50419-346-32Ultravist200 mL in 1 BOTTLEINJECTION20022
50419-346-33Ultravist500 mL in 1 BOTTLEINJECTION50022
50419-346-58Ultravist8 in 1 PACKAGEINJECTION822
50419-346-97Ultravist8 in 1 PACKAGEINJECTION822
50419-346-97Ultravist500 mL in 1 BOTTLEINJECTION50022
50419-346-28Ultravist200 mL in 1 BOTTLEINJECTION2008
50419-346-28Ultravist10 in 1 PACKAGEINJECTION108
50419-346-65Ultravist500 mL in 1 BOTTLEINJECTION5008
50419-346-65Ultravist8 in 1 PACKAGEINJECTION88

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-346-05ML - Milliliter50419-346e0d4d659-777b-4443-9bcc-947710404cbf12012-07-24
50419-346-07ML - Milliliter50419-3468c3efdc3-a5d0-4c3f-9f21-3e4a073dfd5012012-07-24
50419-346-10ML - Milliliter50419-34669f569a1-3cdc-4aa4-8373-b4f251cd4d2a12012-07-24
50419-346-12ML - Milliliter50419-3469108dfd9-729a-4bd7-85ce-a34db66c9ead12012-07-24
50419-346-15ML - Milliliter50419-3460153b6e3-8489-4765-8ef9-fb832c1c624612012-07-24
50419-346-20ML - Milliliter50419-3460a903707-84eb-490c-9b0e-71ba8fabab0412012-07-24
50419-346-25ML - Milliliter50419-346ce59e523-f239-461c-9337-aee0c1e155df12012-07-24
50419-346-28ML - Milliliter50419-3469dc25027-263f-4d1a-9c28-646225f3cea612025-09-12
50419-346-33ML - Milliliter50419-346d64d8b86-a508-4c07-a678-90be753104f812019-05-02
50419-346-50ML - Milliliter50419-346eb15372d-7f57-48f1-ae4f-1fbbf7617e5d12013-03-03
50419-346-58ML - Milliliter50419-34628b091b8-83bd-4238-8c0d-488f3bb3ea2312012-07-24
50419-346-65ML - Milliliter50419-3464c1da143-b438-4edd-a4ed-4671073b070212025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOPROMIDEACTIVE INGREDIENT712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
IOPROMIDEACTIVE MOIETY712BAC33MZULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
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
50419-346ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 6 package rows20230515_d96a7883-d160-40a1-bdbd-2e8d7877cd18.zip
50419-346ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 30 package rows20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip
50419-346ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 4 package rows20230515_65647318-27e4-4f37-bd68-50eea52d6c5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-346-055041903460510 VIAL, GLASS in 1 CARTON (50419-346-05) / 50 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-075041903460710 VIAL, GLASS in 1 CARTON (50419-346-07) > 75 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-105041903461010 VIAL, GLASS in 1 CARTON (50419-346-10) / 100 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-125041903461210 in 1 CARTONHistorical
50419-346-155041903461510 VIAL, GLASS in 1 CARTON (50419-346-15) / 150 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-205041903462010 VIAL, GLASS in 1 CARTON (50419-346-20) / 200 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-265041903462610 BOTTLE in 1 PACKAGE (50419-346-26) / 200 mL in 1 BOTTLE (50419-346-32) 10 bottle2009-12-300000-00-00NoNoCurrent
50419-346-285041903462810 BOTTLE in 1 PACKAGE (50419-346-28) / 200 mL in 1 BOTTLE10 bottle2018-05-040000-00-00NoNoCurrent
50419-346-3250419034632200 mL in 1 BOTTLE200 mlHistorical
50419-346-3350419034633500 mL in 1 BOTTLE500 mlHistorical
50419-346-415041903464110 VIAL, GLASS in 1 CARTON (50419-346-41) > 50 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-435041903464310 VIAL, GLASS in 1 CARTON (50419-346-43) > 100 mL in 1 VIAL, GLASS2009-12-300000-00-00NoNoCurrent
50419-346-4550419034645150 mL in 1 VIAL, GLASS150 mlHistorical
50419-346-58504190346588 BOTTLE in 1 PACKAGE (50419-346-58) / 500 mL in 1 BOTTLE (50419-346-33) 8 bottle2009-12-300000-00-00NoNoCurrent
50419-346-65504190346658 BOTTLE in 1 PACKAGE (50419-346-65) / 500 mL in 1 BOTTLE8 bottle2018-05-040000-00-00NoNoCurrent
50419-346-915041903469110 VIAL, GLASS in 1 CARTON (50419-346-91) / 100 mL in 1 VIAL, GLASS2016-10-110000-00-00NoNoCurrent
50419-346-97504190346978 BOTTLE in 1 PACKAGE (50419-346-97) / 500 mL in 1 BOTTLE8 bottle2009-12-300000-00-00NoNoCurrent