NDC 64370-421

TOLAK

Fluorouracil

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

• Product ID: 64370-421_7e012cc6-3e2a-d6f1-e053-2a91aa0a13da
• NDC: 64370-421
• Product Type: Human Prescription Drug
• Proprietary Name: TOLAK
• Generic Name: Fluorouracil
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-03-15
• Marketing Category: NDA / NDA
• Application Number: NDA022259
• Labeler Name: Pierre Fabre Pharmaceuticals, Inc.
• Substance Name: FLUOROURACIL
• Active Ingredient Strength: 40 mg/g
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64370-421-40

1 TUBE in 1 CARTON (64370-421-40) > 40 g in 1 TUBE

• Marketing Start Date: 2017-03-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64370-421-03 [64370042103]

TOLAK CREAM

• Marketing Category: NDA
• Application Number: NDA022259
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-14
• Marketing End Date: 2020-12-31

NDC 64370-421-83 [64370042183]

TOLAK CREAM

• Marketing Category: NDA
• Application Number: NDA022259
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-19
• Marketing End Date: 2020-12-31

NDC 64370-421-40 [64370042140]

TOLAK CREAM

• Marketing Category: NDA
• Application Number: NDA022259
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-03-15
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROURACIL	40 mg/g

OpenFDA Data

• SPL SET ID: e37ae7a6-7074-4744-8d56-c85d7e4ad587
• Manufacturer:
  • Pierre Fabre Pharmaceuticals, Inc.
• UNII:
  • U3P01618RT
• RxNorm Concept Unique ID - RxCUI:
  • 1669868
  • 1669873

Pharmacological Class

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

Medicade Reported Pricing

64370042140 TOLAK 4% CREAM

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
64370-421	TOLAK	TOLAK
28105-421	TOLAK	TOLAK
0703-3015	Adrucil	Fluorouracil
0703-3018	Adrucil	Fluorouracil
0703-3019	Adrucil	Fluorouracil
0187-5200	Carac	fluorouracil
0187-3204	Efudex	Fluorouracil
16110-812	Fluoroplex	fluorouracil
0378-4791	Fluorouracil	Fluorouracil
16714-178	Fluorouracil	Fluorouracil
16729-276	Fluorouracil	Fluorouracil
16729-542	Fluorouracil	Fluorouracil
21695-829	FLUOROURACIL	fluorouracil
25021-215	fluorouracil	fluorouracil
0378-8078	Fluorouracil Cream	fluorouracil