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United States · US · US:64842-0120_87b2e0c4-3351-4a85-b721-19a0574daafa
LYTGOBI
Orange BookUNIISPLATC L01EN04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTAIHO PHARMACEUTICAL CO., LTD.
CountryUS (United States)
ATC codeL01EN04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1164842012041 BLISTER PACK in 1 CARTON (64842-0120-4) / 21 TABLET in 1 BLISTER PACK
- ndc1164842012051 BLISTER PACK in 1 CARTON (64842-0120-5) / 28 TABLET in 1 BLISTER PACK
- ndc1164842012061 BLISTER PACK in 1 CARTON (64842-0120-6) / 35 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": "64842-0120_87b2e0c4-3351-4a85-b721-19a0574daafa",
"productndc": "64842-0120",
"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": "20230203",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code L01EN04.
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