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 1 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FLUOROURACILFLUOROURACILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f0b60247-89ff-42b5-a55b-61980c2827492026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.1b2f6145-b338-42ed-88a7-f4da65c591642026-07-15Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILFresenius Kabi USA, LLCbeb8c6c5-4b6e-4770-b6d4-718e33c7a2ff2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILBluePoint Laboratoriesc612b05f-f37d-47fa-9c1e-b2d876dd70932026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILBluePoint Laboratoriescdf07a8b-91ee-424f-8c04-34f53dfb82be2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.acca0036-f19c-459b-9dfc-9592f1cd588d2026-07-14Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
FluorouracilFLUOROURACILNORTHSTAR RX LLC52ef5f41-2312-4b55-aa86-abd5bb28b9d32026-07-08Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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