Home Applications 020220 Application 020220
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ULTRAVIST 370 IOPROMIDE INJECTABLE;INJECTION 76.9% Yes Yes 002 ULTRAVIST 300 IOPROMIDE INJECTABLE;INJECTION 62.3% Yes Yes 003 ULTRAVIST 240 IOPROMIDE INJECTABLE;INJECTION 49.9% Yes No 004 ULTRAVIST 150 IOPROMIDE INJECTABLE;INJECTION 31.2% Yes No 005 ULTRAVIST 300 IN PLASTIC CONTAINER IOPROMIDE INJECTABLE;INJECTION 62.3% Yes No
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…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-342 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-342 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-342 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-342 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-344 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-346 Ultravist iopromide Bayer HealthCare Pharmaceuticals Inc. NDA Current