EOVIST

Product NDC: 50419-320
11-digit product format: 504190320
Labeler code: 50419
Product ID: 50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gadoxetate Disodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA022090
Marketing category: NDA
Marketing start: 2008-07-03
Substance: GADOXETATE DISODIUM
Active strength: 181.43 mg/mL
Pharmacologic classes: Gadolinium-based Contrast Agent [EPC], Magnetic Resonance 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022090-001	EOVIST	GADOXETATE DISODIUM	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-07-03
N022090-002	EOVIST	GADOXETATE DISODIUM	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-02-04

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 3 · 82 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	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: EOVIST
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GADOXETATE DISODIUM	181.43 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HOY74VZE0M	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
6218b1e1-cbc3-4c14-bec7-528ac163a561	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
5b2d15dc-225b-aca9-f9ef-b38666fe1e57	Product name	4	20250620
c34d3757-8380-f2a9-d77b-04fccc1c986e	Product name	4	20250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54	Product name	1	20140508
51162ac0-9a99-d9a1-b417-523615d04171	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50419-320-05	2024-01-30	C162847	48780-1	1030e365-3dbc-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use EOVIST® safely and effectively. See full prescribing information for EOVIST. EOVIST (gadoxetate disodium) injection, for intravenous use Initial U.S. Approval: 2008
50419-320-15	2024-01-30	C162847	48780-1	1030e365-3dbc-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use EOVIST® safely and effectively. See full prescribing information for EOVIST. EOVIST (gadoxetate disodium) injection, for intravenous use Initial U.S. Approval: 2008
50419-320-75	2024-01-30	C162847	48780-1	1030e365-3dbc-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use EOVIST® safely and effectively. See full prescribing information for EOVIST. EOVIST (gadoxetate disodium) injection, for intravenous use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-320-05	EOVIST	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	25
50419-320-05	EOVIST	5 in 1 BOX	INJECTION, SOLUTION	5	25
50419-320-15	EOVIST	5 in 1 BOX	INJECTION, SOLUTION	5	25
50419-320-15	EOVIST	15 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	15	25
50419-320-75	EOVIST	5 in 1 BOX	INJECTION, SOLUTION	5	25
50419-320-75	EOVIST	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-320-01	ML - Milliliter	50419-320	90ecee66-7976-4798-a28b-4810e25959aa	1	2013-02-11
50419-320-05	ML - Milliliter	50419-320	b9553651-0644-43d4-b7a6-aac90b278dfc	1	2012-07-24
50419-320-15	ML - Milliliter	50419-320	68996975-ce8b-4a4d-b596-0782b5fe0077	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GADOXETATE DISODIUM	ACTIVE INGREDIENT	HOY74VZE0M	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-320	EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	22	Current NDC, Legacy NDC, 6 package rows	20250328_6218b1e1-cbc3-4c14-bec7-528ac163a561.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
EOVIST	GADOXETATE DISODIUM	Bayer HealthCare Pharmaceuticals Inc.	6218b1e1-cbc3-4c14-bec7-528ac163a561	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022090 application number: NDA022090 ndc (product): 50419-320

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HOY74VZE0M	GADOXETATE DISODIUM	135326-22-6	GADOXETATE DISODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-320-05	50419032005	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE	2008-07-03	0000-00-00	No	No	Current
50419-320-15	50419032015	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE	2008-07-03	0000-00-00	No	No	Current
50419-320-75	50419032075	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE	2008-07-03	0000-00-00	No	No	Current