Ultravist

Product NDC: 50419-347
11-digit product format: 504190347
Labeler code: 50419
Product ID: 50419-347_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: 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

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	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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
df917c3a-59a2-4ed1-8470-8a5394c73325	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50419-347-05	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
50419-347-20	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
50419-347-05	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
50419-347-20	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
50419-347-05	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
50419-347-20	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50419-347-05	Ultravist	50 mL in 1 VIAL, GLASS	INJECTION	50		25
50419-347-20	Ultravist	200 mL in 1 VIAL, GLASS	INJECTION	200		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-347-05	ML - Milliliter	50419-347	3daba04c-853e-45b8-8bd0-0b69cf1c103c	1	2022-07-06
50419-347-20	ML - Milliliter	50419-347	e1236129-e4fb-4c69-a20d-d8db9b17d6df	1	2022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IOPROMIDE	ACTIVE INGREDIENT	712BAC33MZ	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5
IOPROMIDE	ACTIVE MOIETY	712BAC33MZ	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-347	ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	22	Current NDC, Legacy NDC, 2 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): 50419-347

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
712BAC33MZ	IOPROMIDE	73334-07-3	IOPROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-347-05	50419034705	50 mL in 1 VIAL, GLASS (50419-347-05)	50 ml	2022-06-08	0000-00-00	No	No	Current
50419-347-20	50419034720	200 mL in 1 VIAL, GLASS (50419-347-20)	200 ml	2022-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultravist	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	25