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 3 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TromethamineTROMETHAMINEMILLA PHARMACEUTICALS INC.082b1104-502b-47af-95bf-0dbf2422990e2026-01-07Warnings, Adverse reactionsExact identifier
unii: 023C2WHX2V
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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