Application 021425

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	62.3%	Yes	Yes
002	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	76.9%	Yes	Yes
003	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	49.9%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021425-001	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20
N021425-002	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20
N021425-003	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021425-002	ULTRAVIST (PHARMACY BULK)	76.9%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021425-003	ULTRAVIST (PHARMACY BULK)	49.9%	INJECTABLE / INJECTION	RLD	2004-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021425-001	ULTRAVIST (PHARMACY BULK)	62.3%	INJECTABLE / INJECTION	RLD, RS	2002-09-20	`8072bd15b7f6…`

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 ndc (product): 50419-346 ndc (product): 50419-342 ndc (product): 50419-344

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 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
50419-344	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
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74559	SUPPL	2023-06-21
74557	SUPPL	2023-06-20
74388	SUPPL	2023-05-26
74376	SUPPL	2023-05-26
74078	SUPPL	2023-04-27
74065	SUPPL	2023-04-26
70255	SUPPL	2022-02-25
70216	SUPPL	2022-02-22
59564	SUPPL	2019-08-02
59549	SUPPL	2019-08-02
54078	SUPPL	2018-05-10
53602	SUPPL	2018-04-05
53601	SUPPL	2018-04-04
47959	SUPPL	2017-04-12
47886	SUPPL	2017-04-07
5321	SUPPL	2015-07-10
36874	SUPPL	2015-07-09
15422	SUPPL	2012-05-07
36873	SUPPL	2010-07-01
5320	SUPPL	2010-06-29
27727	SUPPL	2010-01-20
5319	SUPPL	2007-09-06
15421	SUPPL	2007-09-04
5317	SUPPL	2004-06-29
36872	SUPPL	2004-04-05
5318	SUPPL	2004-03-16
21645	ORIG	2003-06-26
15420	ORIG	2002-09-20
5316	ORIG	2002-09-20