NDC 52549-4118

Fluorouracil

Fluorouracil

Fluorouracil is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceutical Industries Ltd.. The primary component is Fluorouracil.

Product ID52549-4118_96620eda-0669-4a7b-96ac-40206379d659
NDC52549-4118
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2010-03-05
Marketing CategoryANDA / ANDA
Application NumberANDA090368
Labeler NameTaro Pharmaceutical Industries Ltd.
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52549-4118-2

1 TUBE in 1 CARTON (52549-4118-2) > 25 g in 1 TUBE
Marketing Start Date2010-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52549-4118-2 [52549411802]

Fluorouracil CREAM
Marketing CategoryANDA
Application NumberANDA090368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-05
Inactivation Date2020-01-31

NDC 52549-4118-6 [52549411806]

Fluorouracil CREAM
Marketing CategoryANDA
Application NumberANDA090368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-05
Inactivation Date2020-01-31

NDC 52549-4118-5 [52549411805]

Fluorouracil CREAM
Marketing CategoryANDA
Application NumberANDA090368
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/g

Pharmacological Class

  • Nucleic Acid Synthesis Inhibitors [MoA]
  • Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Fluorouracil" or generic name "Fluorouracil"

NDCBrand NameGeneric Name
0378-4791FluorouracilFluorouracil
16714-178FluorouracilFluorouracil
16729-276FluorouracilFluorouracil
16729-542FluorouracilFluorouracil
21695-829FLUOROURACILfluorouracil
25021-215fluorouracilfluorouracil
68001-266FluorouracilFluorouracil
68083-293FluorouracilFluorouracil
68083-292FluorouracilFluorouracil
68083-269FluorouracilFluorouracil
68083-270FluorouracilFluorouracil
43547-259FluorouracilFluorouracil
43547-258FluorouracilFluorouracil
51672-4063FluorouracilFluorouracil
51672-4062FluorouracilFluorouracil
51672-4118FluorouracilFluorouracil
52549-4118FluorouracilFluorouracil
63323-117FluorouracilFluorouracil
66758-044FluorouracilFluorouracil
66758-054FluorouracilFluorouracil
66530-249FLUOROURACILFLUOROURACIL
66530-258FluorouracilFluorouracil
50090-4264FluorouracilFluorouracil
51862-362FLUOROURACILFLUOROURACIL
50742-483FLUOROURACILFLUOROURACIL
50742-481FLUOROURACILFLUOROURACIL
50742-423FLUOROURACILFLUOROURACIL
50742-482FLUOROURACILFLUOROURACIL
0703-3015AdrucilFluorouracil
0703-3018AdrucilFluorouracil
0703-3019AdrucilFluorouracil
0187-5200Caracfluorouracil
0187-3204EfudexFluorouracil
16110-812Fluoroplexfluorouracil
0378-8078Fluorouracil Creamfluorouracil
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.