FDA.reportPublic FDA data

FLUOROURACIL

Product NDC
21695-829
11-digit product format
216950829
Labeler code
21695
Product ID
21695-829_4d8f6f8f-a69a-48db-8ee1-3b23989cb11f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA077524
Marketing category
ANDA
Marketing start
2008-04-11
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
2017-12-31
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
21695-829-402019-09-24C16284748780-1934fe258-473a-48b1-e053-8cdaa90a720aFluorouracil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-829-40FLUOROURACIL40 g in 1 TUBECREAM401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-829-40GM - Gram21695-8295b2ed722-e3ef-4c65-8b97-377e394dfbd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-829FLUOROURACIL CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120511_4d8f6f8f-a69a-48db-8ee1-3b23989cb11f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105583fluorouracil 5 % Topical CreamPSN4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
105583fluorouracil 50 MG/ML Topical CreamSCD4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
1055835-5-fluorouracil 50 MG/ML Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
1055835-FU 50 MG/ML Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
105583fluorouracil 5 % Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-829-402169508294040 g in 1 TUBE40 gHistorical