🇺🇸
United States · US · US:79378-310_71b050b3-07a6-401f-9526-104383bff7b7
CTEXLI
Orange BookUNIISPLATC A05AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMirum Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA05AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117937831090100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90)
Annotations
UNII (FDA Substance ID)
0GEI24LG0J
CHENODIOL
RxCUI 2323
Orange Book
N219488
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0GEI24LG0J",
"rxcui": "2323",
"inchikey": "RUDATBOHQWOJDD-BSWAIDMHSA-N",
"display_name": "CHENODIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"015384e7-4ac5-4782-a309-e40cd1421c5b": {
"match": "brand_token",
"title": "CTEXLI (CHENODIOL) TABLET, FILM COATED [MIRUM PHARMACEUTICALS INC.]",
"spl_version": "2",
"published_date": "2025-12-25"
}
},
"productid": "79378-310_71b050b3-07a6-401f-9526-104383bff7b7",
"productndc": "79378-310",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219488",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "001",
"approval_date": "Feb 21, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CHENODIOL",
"proprietary_name": "CTEXLI",
"active_ingred_unit": "mg/1",
"application_number": "NDA219488",
"marketing_category": "NDA",
"nonproprietary_name": "chenodiol",
"start_marketing_date": "20250404",
"active_numerator_strength": "250"
}Related drugs
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