Home NDC 50419-344 Ultravist
Product NDC 50419-344
11-digit product format 504190344
Labeler code 50419
Product ID 50419-344_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 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 300 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 50419-344-05 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 50419-344-07 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 50419-344-10 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 50419-344-12 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 50419-344-15 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 50419-344-21 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 50419-344-23 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 50419-344-32 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 50419-344-41 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 50419-344-43 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 50419-344-48 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 50419-344-58 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 50419-344-65 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 50419-344-91 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 50419-344-97 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 50419-344-05 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 50419-344-07 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 50419-344-10 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 50419-344-12 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 50419-344-15 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 50419-344-21 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 50419-344-23 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 50419-344-32 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 50419-344-41 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 50419-344-43 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 50419-344-48 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 50419-344-58 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 50419-344-65 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 50419-344-91 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 50419-344-97 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 50419-344-05 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 50419-344-07 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 50419-344-10 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 50419-344-12 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 50419-344-15 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 50419-344-21 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 50419-344-23 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 50419-344-32 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 50419-344-41 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 50419-344-43 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 50419-344-48 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 50419-344-58 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 50419-344-65 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 50419-344-91 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 50419-344-97 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-344-05 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-05 Ultravist 50 mL in 1 VIAL, GLASS INJECTION 50 25 50419-344-07 Ultravist 75 mL in 1 VIAL, GLASS INJECTION 75 25 50419-344-07 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-10 Ultravist 100 mL in 1 VIAL, GLASS INJECTION 100 25 50419-344-10 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-12 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-12 Ultravist 125 mL in 1 VIAL, GLASS INJECTION 125 25 50419-344-15 Ultravist 150 mL in 1 VIAL, GLASS INJECTION 150 25 50419-344-15 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-21 Ultravist 10 in 1 PACKAGE INJECTION 10 25 50419-344-21 Ultravist 200 mL in 1 BOTTLE INJECTION 200 25 50419-344-23 Ultravist 200 mL in 1 BOTTLE INJECTION 200 25 50419-344-23 Ultravist 10 in 1 PACKAGE INJECTION 10 25 50419-344-32 Ultravist 500 mL in 1 BOTTLE INJECTION 500 25 50419-344-32 Ultravist 8 in 1 PACKAGE INJECTION 8 25 50419-344-41 Ultravist 50 mL in 1 VIAL, GLASS INJECTION 50 25 50419-344-41 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-43 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-43 Ultravist 100 mL in 1 VIAL, GLASS INJECTION 100 25 50419-344-48 Ultravist 500 mL in 1 BOTTLE INJECTION 500 25 50419-344-48 Ultravist 8 in 1 PACKAGE INJECTION 8 25 50419-344-58 Ultravist 8 in 1 PACKAGE INJECTION 8 25 50419-344-58 Ultravist 500 mL in 1 BOTTLE INJECTION 500 25 50419-344-65 Ultravist 8 in 1 PACKAGE INJECTION 8 25 50419-344-65 Ultravist 500 mL in 1 BOTTLE INJECTION 500 25 50419-344-91 Ultravist 100 mL in 1 VIAL, GLASS INJECTION 100 25 50419-344-91 Ultravist 10 in 1 CARTON INJECTION 10 25 50419-344-97 Ultravist 500 mL in 1 BOTTLE INJECTION 500 25 50419-344-97 Ultravist 8 in 1 PACKAGE INJECTION 8 25 50419-344-21 Ultravist 200 mL in 1 BOTTLE INJECTION 200 22 50419-344-21 Ultravist 10 in 1 PACKAGE INJECTION 10 22 50419-344-32 Ultravist 8 in 1 PACKAGE INJECTION 8 22 50419-344-32 Ultravist 500 mL in 1 BOTTLE INJECTION 500 22 50419-344-48 Ultravist 500 mL in 1 BOTTLE INJECTION 500 22 50419-344-48 Ultravist 8 in 1 PACKAGE INJECTION 8 22 50419-344-58 Ultravist 8 in 1 PACKAGE INJECTION 8 22 50419-344-58 Ultravist 500 mL in 1 BOTTLE INJECTION 500 22 50419-344-97 Ultravist 8 in 1 PACKAGE INJECTION 8 22 50419-344-97 Ultravist 500 mL in 1 BOTTLE INJECTION 500 22 50419-344-23 Ultravist 200 mL in 1 BOTTLE INJECTION 200 8 50419-344-23 Ultravist 10 in 1 PACKAGE INJECTION 10 8 50419-344-65 Ultravist 8 in 1 PACKAGE INJECTION 8 8 50419-344-65 Ultravist 500 mL in 1 BOTTLE INJECTION 500 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-344 ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 Current NDC, Legacy NDC, 10 package rows 20230515_d96a7883-d160-40a1-bdbd-2e8d7877cd18.zip 50419-344 ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 Current NDC, Legacy NDC, 30 package rows 20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip 50419-344 ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 4 package rows 20230515_65647318-27e4-4f37-bd68-50eea52d6c5b.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): 50419-344
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-344-05 50419034405 10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-07 50419034407 75 mL in 1 VIAL, GLASS 75 ml Historical 50419-344-10 50419034410 10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-12 50419034412 10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-15 50419034415 10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-21 50419034421 10 BOTTLE in 1 PACKAGE (50419-344-21) / 200 mL in 1 BOTTLE 10 bottle 2009-12-30 0000-00-00 No No Current 50419-344-23 50419034423 10 BOTTLE in 1 PACKAGE (50419-344-23) / 200 mL in 1 BOTTLE 10 bottle 2018-05-04 0000-00-00 No No Current 50419-344-32 50419034432 8 BOTTLE in 1 PACKAGE (50419-344-32) / 500 mL in 1 BOTTLE 8 bottle 2015-10-11 0000-00-00 No No Current 50419-344-41 50419034441 10 VIAL, GLASS in 1 CARTON (50419-344-41) > 50 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-43 50419034443 10 VIAL, GLASS in 1 CARTON (50419-344-43) > 100 mL in 1 VIAL, GLASS 2009-12-30 0000-00-00 No No Current 50419-344-48 50419034448 8 BOTTLE in 1 PACKAGE (50419-344-48) > 500 mL in 1 BOTTLE 8 bottle 2009-12-30 0000-00-00 No No Current 50419-344-58 50419034458 8 BOTTLE in 1 PACKAGE (50419-344-58) / 500 mL in 1 BOTTLE 8 bottle 2009-12-30 0000-00-00 No No Current 50419-344-65 50419034465 8 BOTTLE in 1 PACKAGE (50419-344-65) / 500 mL in 1 BOTTLE 8 bottle 2018-05-04 0000-00-00 No No Current 50419-344-91 50419034491 10 VIAL, GLASS in 1 CARTON (50419-344-91) / 100 mL in 1 VIAL, GLASS 2016-10-11 0000-00-00 No No Current 50419-344-97 50419034497 8 BOTTLE in 1 PACKAGE (50419-344-97) / 500 mL in 1 BOTTLE 8 bottle 2016-10-11 0000-00-00 No No Current