NDC 28105-421

TOLAK

Fluorouracil

TOLAK is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Hill Dermaceuticals, Inc.. The primary component is Fluorouracil.

Product ID28105-421_61b1343b-cc88-4960-a4a2-ce170b3cd3ea
NDC28105-421
Product TypeHuman Prescription Drug
Proprietary NameTOLAK
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-09-18
Marketing CategoryNDA / NDA
Application NumberNDA022259
Labeler NameHILL DERMACEUTICALS, INC.
Substance NameFLUOROURACIL
Active Ingredient Strength0 g/g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 28105-421-40

1 TUBE in 1 CARTON (28105-421-40) > 40 g in 1 TUBE
Marketing Start Date2015-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28105-421-40 [28105042140]

TOLAK CREAM
Marketing CategoryNDA
Application NumberNDA022259
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-09-18

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL.04 g/g

Pharmacological Class

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

Medicade Reported Pricing

28105042140 TOLAK 4% CREAM

Pricing Unit: GM | Drug Type:

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

NDCBrand NameGeneric Name
64370-421TOLAKTOLAK
28105-421TOLAKTOLAK
0703-3015AdrucilFluorouracil
0703-3018AdrucilFluorouracil
0703-3019AdrucilFluorouracil
0187-5200Caracfluorouracil
0187-3204EfudexFluorouracil
16110-812Fluoroplexfluorouracil
0378-4791FluorouracilFluorouracil
16714-178FluorouracilFluorouracil
16729-276FluorouracilFluorouracil
16729-542FluorouracilFluorouracil
21695-829FLUOROURACILfluorouracil
25021-215fluorouracilfluorouracil
0378-8078Fluorouracil Creamfluorouracil

Trademark Results [TOLAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOLAK
TOLAK
85529383 4818184 Live/Registered
Hill Dermaceuticals, Inc.
2012-01-31
TOLAK
TOLAK
77464979 not registered Dead/Abandoned
Hill Dermaceuticals, Inc.
2008-05-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.