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United States · US · US:70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6
Xermelo
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLexicon Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
8G388563M7
TELOTRISTAT ETHYL
RxCUI 1872441
Orange Book
N208794
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8G388563M7",
"rxcui": "1872441",
"inchikey": "MDSQOJYHHZBZKA-GBXCKJPGSA-N",
"display_name": "TELOTRISTAT ETHYL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f11c21f8-f725-445e-b38e-1e4c5b05bcc6": {
"match": "brand_token",
"title": "XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.]",
"spl_version": "6",
"published_date": "2025-10-03"
}
},
"productid": "70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6",
"productndc": "70183-125",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208794",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Feb 28, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TELOTRISTAT ETHYL",
"proprietary_name": "Xermelo",
"active_ingred_unit": "mg/1",
"application_number": "NDA208794",
"marketing_category": "NDA",
"nonproprietary_name": "telotristat ethyl",
"start_marketing_date": "20170301",
"active_numerator_strength": "250"
}Access this data programmatically
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