NDC 64842-1025

LONSURF

Trifluridine And Tipiracil

LONSURF is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Taiho Pharmaceutical Co., Ltd.. The primary component is Trifluridine; Tipiracil Hydrochloride.

• Product ID: 64842-1025_10f81b3e-9ea8-454c-9856-064362002c4d
• NDC: 64842-1025
• Product Type: Human Prescription Drug
• Proprietary Name: LONSURF
• Generic Name: Trifluridine And Tipiracil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-22
• Marketing Category: NDA / NDA
• Application Number: NDA207981
• Labeler Name: Taiho Pharmaceutical Co., Ltd.
• Substance Name: TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/1; mg/1
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Thymidine Phosphorylase Inhibitor [EPC],Thymidine Phosphorylase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 64842-1025-1

20 TABLET, FILM COATED in 1 BOTTLE (64842-1025-1)

• Marketing Start Date: 2015-10-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64842-1025-2 [64842102502]

LONSURF TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207981
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-11

NDC 64842-1025-3 [64842102503]

LONSURF TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207981
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-21

NDC 64842-1025-1 [64842102501]

LONSURF TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207981
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-07

Drug Details

Active Ingredients

Ingredient	Strength
TRIFLURIDINE	15 mg/1

OpenFDA Data

• SPL SET ID: f5beed22-d71d-4c0d-8dca-2c7317d65d85
• Manufacturer:
  • Taiho Pharmaceutical Co., Ltd.
• UNII:
  • RMW9V5RW38
  • 4H59KLQ0A4
• RxNorm Concept Unique ID - RxCUI:
  • 1670316
  • 1670324
  • 1670322
  • 1670311

Pharmacological Class

• Nucleoside Analog [EXT]
• Nucleoside Analog Antiviral [EPC]
• Nucleoside Metabolic Inhibitor [EPC]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Thymidine Phosphorylase Inhibitor [EPC]
• Thymidine Phosphorylase Inhibitors [MoA]

NDC Crossover Matching brand name "LONSURF" or generic name "Trifluridine And Tipiracil"

NDC	Brand Name	Generic Name
64842-1020	LONSURF	trifluridine and tipiracil
64842-1025	LONSURF	trifluridine and tipiracil