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 9 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: QTT17582CB
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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