FDA.reportPublic FDA data

Fluorouracil

Product NDC
16729-276
11-digit product format
167290276
Labeler code
16729
Product ID
16729-276_4a6723ea-dd4c-3f28-e063-6394a90a7378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA040798
Marketing category
ANDA
Marketing start
2014-03-14
Substance
FLUOROURACIL
Active strength
50 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluorouracil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROURACIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3P01618RT
Rxcui239177, 1791701, 1791736

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dc9482d-9b87-4471-9708-4f1b4585846bProduct name220250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cbProduct name520250630
dc0d2364-4811-4665-a3ee-7ed8c7301465Product name220171219
62fb8671-1693-49d8-8aab-0c1bfdd6794eProduct name120151005
878ca466-81fd-9d24-1349-31baf36065c6Product name220150506
630d1bc2-ae6b-fd31-1264-c4733e788193Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791736fluorouracil 1 GM in 20 ML InjectionPSN66d451fe-2436-494c-80c5-4528c8e343696
239177fluorouracil 50 MG/ML Injectable SolutionPSN66d451fe-2436-494c-80c5-4528c8e343696
1791701fluorouracil 500 MG in 10 ML InjectionPSN66d451fe-2436-494c-80c5-4528c8e343696
179170110 ML fluorouracil 50 MG/ML InjectionSCD66d451fe-2436-494c-80c5-4528c8e343696
179173620 ML fluorouracil 50 MG/ML InjectionSCD66d451fe-2436-494c-80c5-4528c8e343696
239177fluorouracil 50 MG/ML Injectable SolutionSCD66d451fe-2436-494c-80c5-4528c8e343696
179170110 ML 5-5-fluorouracil 50 MG/ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
179170110 ML 5-FU 50 MG/ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
179173620 ML 5-5-fluorouracil 50 MG/ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
179173620 ML 5-FU 50 MG/ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
2391775-5-fluorouracil 50 MG/ML Injectable SolutionSY66d451fe-2436-494c-80c5-4528c8e343696
2391775-FU 50 MG/ML Injectable SolutionSY66d451fe-2436-494c-80c5-4528c8e343696
239177fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable SolutionSY66d451fe-2436-494c-80c5-4528c8e343696
1791736fluorouracil 1 GM per 20 ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
239177fluorouracil 2.5 GM per 50 ML Injectable SolutionSY66d451fe-2436-494c-80c5-4528c8e343696
1791701fluorouracil 500 MG per 10 ML InjectionSY66d451fe-2436-494c-80c5-4528c8e343696
1791736fluorouracil 1 GM in 20 ML InjectionPSN8eff167f-203a-4a81-b2fc-d8773bc3555e5
239177fluorouracil 50 MG/ML Injectable SolutionPSN8eff167f-203a-4a81-b2fc-d8773bc3555e5
1791701fluorouracil 500 MG in 10 ML InjectionPSN8eff167f-203a-4a81-b2fc-d8773bc3555e5
179170110 ML fluorouracil 50 MG/ML InjectionSCD8eff167f-203a-4a81-b2fc-d8773bc3555e5
179173620 ML fluorouracil 50 MG/ML InjectionSCD8eff167f-203a-4a81-b2fc-d8773bc3555e5
239177fluorouracil 50 MG/ML Injectable SolutionSCD8eff167f-203a-4a81-b2fc-d8773bc3555e5
179170110 ML 5-5-fluorouracil 50 MG/ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
179170110 ML 5-FU 50 MG/ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
179173620 ML 5-5-fluorouracil 50 MG/ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
179173620 ML 5-FU 50 MG/ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
2391775-5-fluorouracil 50 MG/ML Injectable SolutionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
2391775-FU 50 MG/ML Injectable SolutionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
239177fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable SolutionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
1791736fluorouracil 1 GM per 20 ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
239177fluorouracil 2.5 GM per 50 ML Injectable SolutionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5
1791701fluorouracil 500 MG per 10 ML InjectionSY8eff167f-203a-4a81-b2fc-d8773bc3555e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-276-031672902760310 mL in 1 VIAL10 mlHistorical
16729-276-051672902760520 mL in 1 VIAL20 mlHistorical
16729-276-11167290276111 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-11) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2014-03-140000-00-00NoNoCurrent
16729-276-38167290276381 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-38) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2014-03-140000-00-00NoNoCurrent
16729-276-671672902766710 VIAL in 1 CARTON (16729-276-67) / 20 mL in 1 VIAL (16729-276-05) 10 vial2014-03-140000-00-00NoNoCurrent
16729-276-681672902766810 VIAL in 1 CARTON (16729-276-68) / 10 mL in 1 VIAL (16729-276-03) 10 vial2014-03-250000-00-00NoNoCurrent