FDA.reportPublic FDA data

Fluorouracil

Product NDC
51672-4118
11-digit product format
516724118
Labeler code
51672
Product ID
51672-4118_170232f3-4992-1e1a-e063-6394a90a38e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA090368
Marketing category
ANDA
Marketing start
2010-03-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluorouracil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROURACIL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3P01618RT
Rxcui105583

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dc9482d-9b87-4471-9708-4f1b4585846bProduct name220250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cbProduct name520250630
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51672-4118-2Fluorouracil25 g in 1 TUBECREAM2510
51672-4118-2Fluorouracil1 in 1 CARTONCREAM110
51672-4118-5Fluorouracil5 g in 1 TUBECREAM510
51672-4118-6Fluorouracil40 g in 1 TUBECREAM4010
51672-4118-6Fluorouracil1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4118-6GM - Gram51672-411817aecad1-bfad-4ed3-827c-305727b88d8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluorouracilACTIVE INGREDIENTU3P01618RTFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
FluorouracilACTIVE MOIETYU3P01618RTFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RFLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4118FLUOROURACIL CREAM [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 5 package rows20240427_acca0036-f19c-459b-9dfc-9592f1cd588d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105583fluorouracil 5 % Topical CreamPSNacca0036-f19c-459b-9dfc-9592f1cd588d10
105583fluorouracil 50 MG/ML Topical CreamSCDacca0036-f19c-459b-9dfc-9592f1cd588d10
1055835-5-fluorouracil 50 MG/ML Topical CreamSYacca0036-f19c-459b-9dfc-9592f1cd588d10
1055835-FU 50 MG/ML Topical CreamSYacca0036-f19c-459b-9dfc-9592f1cd588d10
105583fluorouracil 5 % Topical CreamSYacca0036-f19c-459b-9dfc-9592f1cd588d10
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
105583fluorouracil 5 % Topical CreamPSN03b1a351-5a63-5bcb-e063-6294a90a7c5c1
105583fluorouracil 50 MG/ML Topical CreamSCD03b1a351-5a63-5bcb-e063-6294a90a7c5c1
1055835-5-fluorouracil 50 MG/ML Topical CreamSY03b1a351-5a63-5bcb-e063-6294a90a7c5c1
1055835-FU 50 MG/ML Topical CreamSY03b1a351-5a63-5bcb-e063-6294a90a7c5c1
105583fluorouracil 5 % Topical CreamSY03b1a351-5a63-5bcb-e063-6294a90a7c5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4118-2516724118021 TUBE in 1 CARTON (51672-4118-2) / 25 g in 1 TUBE1 tube2017-03-170000-00-00NoNoCurrent
51672-4118-5516724118055 g in 1 TUBE (51672-4118-5) 5 g2017-03-170000-00-00NoNoCurrent
51672-4118-6516724118061 TUBE in 1 CARTON (51672-4118-6) / 40 g in 1 TUBE1 tube2017-03-170000-00-00NoNoCurrent