FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOXETATE DISODIUM181.43 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHOY74VZE0M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
5b2d15dc-225b-aca9-f9ef-b38666fe1e57Product name420250620
c34d3757-8380-f2a9-d77b-04fccc1c986eProduct name420250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-320-052024-01-30C16284748780-11030e365-3dbc-111a-e063-dadaa90a10e2These 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
50419-320-152024-01-30C16284748780-11030e365-3dbc-111a-e063-dadaa90a10e2These 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
50419-320-752024-01-30C16284748780-11030e365-3dbc-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
50419-320-05EOVIST10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1025
50419-320-05EOVIST5 in 1 BOXINJECTION, SOLUTION525
50419-320-15EOVIST5 in 1 BOXINJECTION, SOLUTION525
50419-320-15EOVIST15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1525
50419-320-75EOVIST5 in 1 BOXINJECTION, SOLUTION525
50419-320-75EOVIST10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-320-01ML - Milliliter50419-32090ecee66-7976-4798-a28b-4810e25959aa12013-02-11
50419-320-05ML - Milliliter50419-320b9553651-0644-43d4-b7a6-aac90b278dfc12012-07-24
50419-320-15ML - Milliliter50419-32068996975-ce8b-4a4d-b596-0782b5fe007712013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GADOXETATE DISODIUMACTIVE INGREDIENTHOY74VZE0MEOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NEOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VEOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0REOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-320EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 6 package rows20250328_6218b1e1-cbc3-4c14-bec7-528ac163a561.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50419-320-05504190320055 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE2008-07-030000-00-00NoNoCurrent
50419-320-15504190320155 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE2008-07-030000-00-00NoNoCurrent
50419-320-75504190320755 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE2008-07-030000-00-00NoNoCurrent