FDA.reportPublic FDA data

Fluorouracil

Product NDC
52549-4118
11-digit product format
525494118
Labeler code
52549
Product ID
52549-4118_96620eda-0669-4a7b-96ac-40206379d659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceutical Industries Ltd.
Application
ANDA090368
Marketing category
ANDA
Marketing start
2010-03-05
Marketing end
0000-00-00
Substance
FLUOROURACIL
Active strength
50 mg/g
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52549-4118-22020-01-31C16284748780-19d75b9d0-af93-f424-e053-dadaa90a57ceFluorouracil Topical Cream USP, 5%
52549-4118-52020-01-31C16284748780-19d75b9d0-af93-f424-e053-dadaa90a57ceFluorouracil Topical Cream USP, 5%
52549-4118-62020-01-31C16284748780-19d75b9d0-af93-f424-e053-dadaa90a57ceFluorouracil Topical Cream USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52549-4118-2Fluorouracil1 in 1 CARTONCREAM11
52549-4118-2Fluorouracil25 g in 1 TUBECREAM251
52549-4118-5Fluorouracil5 g in 1 TUBECREAM51
52549-4118-6Fluorouracil40 g in 1 TUBECREAM401
52549-4118-6Fluorouracil1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluorouracilACTIVE INGREDIENTU3P01618RTFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
FluorouracilACTIVE MOIETYU3P01618RTFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
waterINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52549-4118FLUOROURACIL CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]1Legacy NDC, 5 package rows20100819_9a2c044d-83e4-42b4-9797-c344b8d3d152.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105583fluorouracil 5 % Topical CreamPSN9a2c044d-83e4-42b4-9797-c344b8d3d1521
105583fluorouracil 50 MG/ML Topical CreamSCD9a2c044d-83e4-42b4-9797-c344b8d3d1521
1055835-5-fluorouracil 50 MG/ML Topical CreamSY9a2c044d-83e4-42b4-9797-c344b8d3d1521
1055835-FU 50 MG/ML Topical CreamSY9a2c044d-83e4-42b4-9797-c344b8d3d1521
105583fluorouracil 5 % Topical CreamSY9a2c044d-83e4-42b4-9797-c344b8d3d1521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52549-4118-2525494118021 in 1 CARTONHistorical
52549-4118-5525494118055 g in 1 TUBE5 gHistorical
52549-4118-65254941180640 g in 1 TUBE40 gHistorical