FDA.reportPublic FDA data

NDC 66758-044-01 - 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
66758-044
Requested NDC
66758-044-01
Package NDCs from labels
66758-044-01, 66758-044-03
Manufacturer
Sandoz Inc
Effective date
2010-05-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluorouracil - Sandoz IncSandoz Inc2010-05-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66758-044-032020-05-04C16284748780-1956f9ecf-c9e1-621f-e053-dbdaa90a74adFluorouracil Injection, USP
66758-044-032019-10-21C16284748780-1956f9ecf-c9e1-621f-e053-dbdaa90a74adFluorouracil Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-044-01ML - Milliliter66758-0447d3b4898-cc37-4b11-935f-2d63e117382c12012-07-24
66758-044-03ML - Milliliter66758-044bbbba456-ec8e-4eed-98bd-af78cbe9974712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluorouracilACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [SANDOZ INC]11
FluorouracilACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [SANDOZ INC]11
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [SANDOZ INC]11
waterINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL INJECTION, SOLUTION [SANDOZ INC]11

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 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILXiromed LLC19735014-c6fb-0a05-c330-2e9389c712162026-02-19Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILXiromed LLCf4b0cae1-a2fc-2991-d663-3b729503cd1c2026-02-19Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILAccord Healthcare, Inc.8eff167f-203a-4a81-b2fc-d8773bc3555e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILAccord Healthcare, Inc.66d451fe-2436-494c-80c5-4528c8e343692026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
fluorouracilFLUOROURACILSagent Pharmaceuticals37e35e8c-5d51-413b-a3a0-b72a18caaf652026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FLUOROURACILFLUOROURACILEugia US LLC697816ce-dc05-4943-b7f0-2f0b125e93b72026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FLUOROURACILFLUOROURACILEugia US LLC199ef964-8a9b-403e-a2ae-759280b3d1d12026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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