FLUOROURACIL

Product NDC
66530-249
11-digit product format
665300249
Labeler code
66530
Product ID
66530-249_d71da1a5-c6a1-45a4-908f-0cd1a21f8537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
Spear Dermatology Products
Application
ANDA077524
Marketing category
ANDA
Marketing start
2008-04-11
Marketing end
2022-08-31
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66530-249-40GM - Gram66530-249f20a9709-add6-4490-8d35-26394f8698fb12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105583fluorouracil 5 % Topical CreamPSN4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
105583fluorouracil 5 % Topical CreamPSNbf851a7f-902d-4f1d-9d19-fd9cd5701fcd1
105583fluorouracil 50 MG/ML Topical CreamSCD4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
105583fluorouracil 50 MG/ML Topical CreamSCDbf851a7f-902d-4f1d-9d19-fd9cd5701fcd1
1055835-5-fluorouracil 50 MG/ML Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
1055835-5-fluorouracil 50 MG/ML Topical CreamSYbf851a7f-902d-4f1d-9d19-fd9cd5701fcd1
1055835-FU 50 MG/ML Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
1055835-FU 50 MG/ML Topical CreamSYbf851a7f-902d-4f1d-9d19-fd9cd5701fcd1
105583fluorouracil 5 % Topical CreamSY4d8f6f8f-a69a-48db-8ee1-3b23989cb11f1
105583fluorouracil 5 % Topical CreamSYbf851a7f-902d-4f1d-9d19-fd9cd5701fcd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66530-249-406653002494040 g in 1 TUBE (66530-249-40) 40 g2008-04-112022-08-31NoNoCurrent