FDA.reportPublic FDA data

NDC 50419-320-01 - EOVIST

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50419-320
Requested NDC
50419-320-01
Package NDCs from labels
50419-320-05, 50419-320-15, 50419-320-75, 50419-320-01
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EOVIST - Bayer HealthCare Pharmaceuticals Inc.Bayer HealthCare Pharmaceuticals Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

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 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

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

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 4 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.