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 ID64842-1025_10f81b3e-9ea8-454c-9856-064362002c4d
NDC64842-1025
Product TypeHuman Prescription Drug
Proprietary NameLONSURF
Generic NameTrifluridine And Tipiracil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-09-22
Marketing CategoryNDA / NDA
Application NumberNDA207981
Labeler NameTaiho Pharmaceutical Co., Ltd.
Substance NameTRIFLURIDINE; TIPIRACIL HYDROCHLORIDE
Active Ingredient Strength15 mg/1; mg/1
Pharm ClassesNucleoside 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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 64842-1025-1

20 TABLET, FILM COATED in 1 BOTTLE (64842-1025-1)
Marketing Start Date2015-10-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64842-1025-2 [64842102502]

LONSURF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207981
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-11

NDC 64842-1025-3 [64842102503]

LONSURF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207981
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-21

NDC 64842-1025-1 [64842102501]

LONSURF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207981
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-07

Drug Details

Active Ingredients

IngredientStrength
TRIFLURIDINE15 mg/1

OpenFDA Data

SPL SET ID:f5beed22-d71d-4c0d-8dca-2c7317d65d85
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    64842-1020LONSURFtrifluridine and tipiracil
    64842-1025LONSURFtrifluridine and tipiracil

    Trademark Results [LONSURF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LONSURF
    LONSURF
    85742542 4438626 Live/Registered
    Taiho Pharmaceutical Co., Ltd.
    2012-10-01
    LONSURF
    LONSURF
    79183501 5121586 Live/Registered
    TAIHO PHARMACEUTICAL CO., LTD.
    2015-10-22

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