Fluorouracil

Product NDC
50090-4264
11-digit product format
500904264
Labeler code
50090
Product ID
50090-4264_6982da69-985f-4b32-bb1c-bf6d1d4ed919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
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
No
Listing certified through
2022-12-31
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
50090-4264-02023-01-30C16284748780-1f386c649-a1c6-0266-e053-dadaa90a7c1aFluorouracil Topical Cream USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4264-0Fluorouracil40 g in 1 TUBECREAM405
50090-4264-0Fluorouracil1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4264-0GM - Gram50090-4264ff8e2bb5-7a64-42a5-bc90-6299586a619412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4264FLUOROURACIL CREAM [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210617_ef67a3ae-144e-46db-836e-905e16e6d4c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105583fluorouracil 5 % Topical CreamPSNef67a3ae-144e-46db-836e-905e16e6d4c25
105583fluorouracil 50 MG/ML Topical CreamSCDef67a3ae-144e-46db-836e-905e16e6d4c25
1055835-5-fluorouracil 50 MG/ML Topical CreamSYef67a3ae-144e-46db-836e-905e16e6d4c25
1055835-FU 50 MG/ML Topical CreamSYef67a3ae-144e-46db-836e-905e16e6d4c25
105583fluorouracil 5 % Topical CreamSYef67a3ae-144e-46db-836e-905e16e6d4c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4264-0500904264001 TUBE in 1 CARTON (50090-4264-0) > 40 g in 1 TUBE1 tube2019-04-120000-00-00NoNoCurrent