LYTGOBI

Orange BookUNIISPLATC L01EN04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTAIHO PHARMACEUTICAL CO., LTD.

CountryUS (United States)

ATC codeL01EN04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6484201277
1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

4B93MGE4AL

FUTIBATINIB

Orange Book

N214801

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4B93MGE4AL",
    "rxcui": null,
    "inchikey": "KEIPNCCJPRMIAX-HNNXBMFYSA-N",
    "display_name": "FUTIBATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0b1332a1-0581-4707-9bf6-1eccfa39bef4": {
      "match": "brand_token",
      "title": "LYTGOBI (FUTIBATINIB) TABLET LYTGOBI KIT [TAIHO PHARMACEUTICAL CO., LTD.]",
      "spl_version": "8",
      "published_date": "2026-06-02"
    }
  },
  "productid": "64842-0127_87b2e0c4-3351-4a85-b721-19a0574daafa",
  "productndc": "64842-0127",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214801",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Sep 30, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "16MG",
        "product_no": "002",
        "approval_date": "Jul 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FUTIBATINIB",
  "proprietary_name": "LYTGOBI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214801",
  "marketing_category": "NDA",
  "nonproprietary_name": "FUTIBATINIB",
  "start_marketing_date": "20260601",
  "active_numerator_strength": "16"
}

Related drugs

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