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United States · US · US:70720-125_ba59d050-c350-492f-a421-f4b64f6fc60e
Xermelo
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTerSera Therapeutics LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170720125854 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK
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": "70720-125_ba59d050-c350-492f-a421-f4b64f6fc60e",
"productndc": "70720-125",
"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": "20201005",
"active_numerator_strength": "250"
}Access this data programmatically
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