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United States · US · US:51144-001_892c322b-be43-4180-89f7-4e3619a8b58f
TUKYSA
Orange BookUNIISPLATC L01EH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSEAGEN INC.
CountryUS (United States)
ATC codeL01EH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11511440016060 TABLET in 1 BOTTLE (51144-001-60)
Annotations
UNII (FDA Substance ID)
234248D0HH
TUCATINIB
RxCUI 2361285
Orange Book
N213411
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "234248D0HH",
"rxcui": "2361285",
"inchikey": "SDEAXTCZPQIFQM-UHFFFAOYSA-N",
"display_name": "TUCATINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f27eb1b9-b7fc-424e-988f-84dd7bb195a3": {
"match": "brand_token",
"title": "TUKYSA (TUCATINIB) TABLET [SEAGEN INC.]",
"spl_version": "9",
"published_date": "2024-11-05"
}
},
"productid": "51144-001_892c322b-be43-4180-89f7-4e3619a8b58f",
"productndc": "51144-001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213411",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Apr 17, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "002",
"approval_date": "Apr 17, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TUCATINIB",
"proprietary_name": "TUKYSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA213411",
"marketing_category": "NDA",
"nonproprietary_name": "tucatinib",
"start_marketing_date": "20200417",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EH03.
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