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United States · US · US:64842-1020_15b86e86-8940-44e3-921c-2e0b97180ea1

LONSURF

Orange BookUNIISPLATC S01AD

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTaiho Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeS01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6484210201
    20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1)
  • ndc11
    6484210202
    40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2)
  • ndc11
    6484210203
    60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3)

Annotations

UNII (FDA Substance ID)
4H59KLQ0A4
TIPIRACIL HYDROCHLORIDE
RxCUI 1670303
Orange Book
N207981
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4H59KLQ0A4",
    "rxcui": "1670303",
    "inchikey": "KGHYQYACJRXCAT-UHFFFAOYSA-N",
    "display_name": "TIPIRACIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f5beed22-d71d-4c0d-8dca-2c7317d65d85": {
      "match": "brand_token",
      "title": "LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.]",
      "spl_version": "15",
      "published_date": "2025-11-18"
    }
  },
  "productid": "64842-1020_15b86e86-8940-44e3-921c-2e0b97180ea1",
  "productndc": "64842-1020",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207981",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 6.14MG BASE;15MG",
        "product_no": "001",
        "approval_date": "Sep 22, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 8.19MG BASE;20MG",
        "product_no": "002",
        "approval_date": "Sep 22, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE",
  "proprietary_name": "LONSURF",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA207981",
  "marketing_category": "NDA",
  "nonproprietary_name": "trifluridine and tipiracil",
  "start_marketing_date": "20150922",
  "active_numerator_strength": "8.19; 20"
}

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