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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FLUOROURACILFLUOROURACILMayne Pharma Inc.06475bd8-66d9-4f88-90e4-b367480dab392021-11-04Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILMylan Pharmaceuticals Inc.744737c5-0d96-4214-82ab-6cff016b1ea02021-06-30Warnings, Adverse reactionsExact identifier
unii: U3P01618RT
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
4f17a66d-5d04-430f-8384-4032be81bcd61911e06a-2f16-4b99-adfa-4b914d559e1e2020-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 1911e06a-2f16-4b99-adfa-4b914d559e1e
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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