lonsurf

Generic: trifluridine and tipiracil

Labeler: taiho pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lonsurf
Generic Name trifluridine and tipiracil
Labeler taiho pharmaceutical co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tipiracil hydrochloride 8.19 mg/1, trifluridine 20 mg/1

Manufacturer
Taiho Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 64842-1020
Product ID 64842-1020_15b86e86-8940-44e3-921c-2e0b97180ea1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207981
Listing Expiration 2026-12-31
Marketing Start 2015-09-22

Pharmacologic Class

Established (EPC)
nucleoside analog antiviral [epc] nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 648421020
Hyphenated Format 64842-1020

Supplemental Identifiers

RxCUI
1670311 1670316 1670322 1670324
UNII
RMW9V5RW38 4H59KLQ0A4
NUI
N0000175459 N0000175466 N0000175595 N0000000233

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lonsurf (source: ndc)
Generic Name trifluridine and tipiracil (source: ndc)
Application Number NDA207981 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8.19 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1)
  • 40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3)
source: ndc

Packages (3)

64842-1020-1 20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1) 64842-1020-2 40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2) 64842-1020-3 60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3)

Ingredients (2)

tipiracil hydrochloride (8.19 mg/1) trifluridine (20 mg/1)

Linked Drug Pages (1)

LONSURF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15b86e86-8940-44e3-921c-2e0b97180ea1", "openfda": {"nui": ["N0000175459", "N0000175466", "N0000175595", "N0000000233"], "unii": ["RMW9V5RW38", "4H59KLQ0A4"], "rxcui": ["1670311", "1670316", "1670322", "1670324"], "spl_set_id": ["f5beed22-d71d-4c0d-8dca-2c7317d65d85"], "pharm_class_epc": ["Nucleoside Analog Antiviral [EPC]", "Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Taiho Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1)", "package_ndc": "64842-1020-1", "marketing_start_date": "20151007"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2)", "package_ndc": "64842-1020-2", "marketing_start_date": "20151111"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3)", "package_ndc": "64842-1020-3", "marketing_start_date": "20151021"}], "brand_name": "LONSURF", "product_id": "64842-1020_15b86e86-8940-44e3-921c-2e0b97180ea1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Metabolic Inhibitor [EPC]", "Thymidine Phosphorylase Inhibitor [EPC]", "Thymidine Phosphorylase Inhibitors [MoA]"], "product_ndc": "64842-1020", "generic_name": "trifluridine and tipiracil", "labeler_name": "Taiho Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LONSURF", "active_ingredients": [{"name": "TIPIRACIL HYDROCHLORIDE", "strength": "8.19 mg/1"}, {"name": "TRIFLURIDINE", "strength": "20 mg/1"}], "application_number": "NDA207981", "marketing_category": "NDA", "marketing_start_date": "20150922", "listing_expiration_date": "20261231"}