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 5 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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