FDA.reportPublic FDA data

NDC 16729-276-03 - 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
16729-276
Requested NDC
16729-276-03
Package NDCs from labels
16729-276-03, 16729-276-68, 16729-276-05, 16729-276-67, 16729-276-11, 16729-276-38
Manufacturer
Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd
Effective date
2026-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluorouracil - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2026-02-09HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2026-02-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-276-03Fluorouracil10 mL in 1 VIALINJECTION, SOLUTION106
16729-276-05Fluorouracil20 mL in 1 VIALINJECTION, SOLUTION206
16729-276-67Fluorouracil10 in 1 CARTONINJECTION, SOLUTION106
16729-276-68Fluorouracil10 in 1 CARTONINJECTION, SOLUTION106
16729-276-11Fluorouracil1 in 1 CARTONINJECTION, SOLUTION15
16729-276-11Fluorouracil50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION505
16729-276-38Fluorouracil1 in 1 CARTONINJECTION, SOLUTION15
16729-276-38Fluorouracil100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-276FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]5Current NDC, Legacy NDC, 4 package rows20240510_66d451fe-2436-494c-80c5-4528c8e34369.zip
16729-276FLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]4Current NDC, Legacy NDC, 4 package rows20240531_8eff167f-203a-4a81-b2fc-d8773bc3555e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-276-03ML - Milliliter16729-2768225afca-1943-45ca-8319-1f010a65914112015-06-09
16729-276-05ML - Milliliter16729-276462e7a48-db23-489e-97f0-234fff0b0ca612015-06-09
16729-276-11ML - Milliliter16729-276e018f89b-6296-45ff-b7d2-de969ff2634712014-04-03
16729-276-38ML - Milliliter16729-27656948694-48d7-479b-ad6d-f3f62fa8392012014-04-03
16729-276-67ML - Milliliter16729-27622852805-70ba-4211-901a-3baedb9541a812014-04-03
16729-276-68ML - Milliliter16729-2762d9dc808-4a3d-499e-809d-dd03d0676d1712014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
FluorouracilACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
FluorouracilACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]2

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
rxcui: 1791736
rxcui: 1791701
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
rxcui: 1791736
rxcui: 1791701
rxcui: 239177
unii: U3P01618RT
FluorouracilFLUOROURACILBluePoint Laboratoriesc612b05f-f37d-47fa-9c1e-b2d876dd70932026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 239177
unii: U3P01618RT
FluorouracilFLUOROURACILBluePoint Laboratoriescdf07a8b-91ee-424f-8c04-34f53dfb82be2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 239177
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.