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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

  • ndc11
    7937831090
    100 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"
}

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