LYTGOBI

Orange BookSPL

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

Identification

ManufacturerTAIHO PHARMACEUTICAL CO., LTD.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6484201288
1 BLISTER PACK in 1 CARTON (64842-0128-8) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N214801

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "64842-0128_87b2e0c4-3351-4a85-b721-19a0574daafa",
  "productndc": "64842-0128",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "LYTGOBI",
  "active_ingred_unit": null,
  "application_number": "NDA214801",
  "marketing_category": "NDA",
  "nonproprietary_name": "LYTGOBI",
  "start_marketing_date": "20260601",
  "active_numerator_strength": null
}

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