FDA.reportPublic FDA data

NDC 55150-497-01 - FLUOROURACIL

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
55150-497
Requested NDC
55150-497-01
Package NDCs from labels
55150-497-01, 55150-497-10
Manufacturer
Eugia US LLC | EUGIA Pharma Specialities Limited
Effective date
2026-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FLUOROURACIL - Eugia US LLC | EUGIA Pharma Specialities LimitedEugia US LLC | EUGIA Pharma Specialities Limited2026-01-19Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-497-01FLUOROURACIL20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
55150-497-10FLUOROURACIL10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-497FLUOROURACIL INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, 2 package rows20240707_199ef964-8a9b-403e-a2ae-759280b3d1d1.zip

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 2 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILFresenius Kabi USA, LLCb4328ae3-f48f-40b1-9719-1c1aced7c7342026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
FluorouracilFLUOROURACILFresenius Kabi USA, LLCa85ab26a-05ea-498f-8f34-564a925fa9d92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILFresenius Kabi USA, LLC21af1777-87f7-4e40-9917-f1677e7ff1a52026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
FLUOROURACILFLUOROURACILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b268684b-487f-4716-a2e8-6e6d3e117b142026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.de8a3fce-85a9-4a77-a3cd-e50179b930982026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.a0cd6301-c6e0-4b62-8683-39c99913db242026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILFresenius Kabi USA, LLCc45f5286-a52b-43e5-8a6f-d0312e7da0c82026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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