Home NDC 50419-348 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020220-001 ULTRAVIST 370 IOPROMIDE 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 N020220-002 ULTRAVIST 300 IOPROMIDE 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 N020220-003 ULTRAVIST 240 IOPROMIDE 49.9% INJECTABLE / INJECTION RLD 1995-05-10 N020220-004 ULTRAVIST 150 IOPROMIDE 31.2% INJECTABLE / INJECTION RLD 1995-05-10 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER IOPROMIDE 62.3% INJECTABLE / INJECTION RLD 2008-11-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020220-001 ULTRAVIST 370 76.9% INJECTABLE / INJECTION RLD, RS 1995-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020220-002 ULTRAVIST 300 62.3% INJECTABLE / INJECTION RLD, RS 1995-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020220-003 ULTRAVIST 240 49.9% INJECTABLE / INJECTION RLD 1995-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020220-004 ULTRAVIST 150 31.2% INJECTABLE / INJECTION RLD 1995-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020220-005 ULTRAVIST 300 IN PLASTIC CONTAINER 62.3% INJECTABLE / INJECTION RLD 2008-11-18 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base Ultravist
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOPROMIDE 370 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 712BAC33MZ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50419-348-05 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-10 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-11 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-12 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-13 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-20 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-21 2024-08-21 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 use Initial U.S. Approval: 1995 50419-348-05 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-10 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-11 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-12 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-13 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-20 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-21 2024-07-30 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 use Initial U.S. Approval: 1995 50419-348-05 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-10 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-11 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-12 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-13 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-20 2024-01-30 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 use Initial U.S. Approval: 1995 50419-348-21 2024-01-30 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 use Initial U.S. Approval: 1995
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-348 ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 Current NDC, Legacy NDC, 11 package rows 20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultravist IOPROMIDE Bayer HealthCare Pharmaceuticals Inc. df917c3a-59a2-4ed1-8470-8a5394c73325 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020220 application number: NDA020220 ndc (product): 50419-348
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-348-05 50419034805 10 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS 2022-06-08 0000-00-00 No No Current 50419-348-10 50419034810 100 mL in 1 VIAL, GLASS (50419-348-10) 100 ml 2022-06-08 0000-00-00 No No Current 50419-348-11 50419034811 100 mL in 1 VIAL, GLASS (50419-348-11) 100 ml 2022-06-08 0000-00-00 No No Current 50419-348-12 50419034812 10 VIAL, GLASS in 1 CARTON (50419-348-12) / 100 mL in 1 VIAL, GLASS 2022-06-08 0000-00-00 No No Current 50419-348-13 50419034813 10 VIAL, GLASS in 1 CARTON (50419-348-13) / 100 mL in 1 VIAL, GLASS 2022-06-08 0000-00-00 No No Current 50419-348-20 50419034820 200 mL in 1 VIAL, GLASS (50419-348-20) 200 ml 2022-06-08 0000-00-00 No No Current 50419-348-21 50419034821 10 VIAL, GLASS in 1 CARTON (50419-348-21) / 200 mL in 1 VIAL, GLASS 2022-06-08 0000-00-00 No No Current