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United States · US · US:72426-118_75423e10-bf22-4ef2-81de-fa6451541020

Nexletol

Orange BookUNIISPLATC C10AX15

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEsperion Therapeutics, Inc.
CountryUS (United States)
ATC codeC10AX15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7242611803
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)
  • ndc11
    7242611899
    7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99)

Annotations

UNII (FDA Substance ID)
1EJ6Z6Q368
BEMPEDOIC ACID
RxCUI 2282403
Orange Book
N211616
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1EJ6Z6Q368",
    "rxcui": "2282403",
    "inchikey": "HYHMLYSLQUKXKP-UHFFFAOYSA-N",
    "display_name": "BEMPEDOIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "88d06d89-a3da-40b4-b273-8f4f7d56c4c9": {
      "match": "brand_token",
      "title": "NEXLETOL (BEMPEDOIC ACID) TABLET, FILM COATED [ESPERION THERAPEUTICS, INC.]",
      "spl_version": "19",
      "published_date": "2026-01-19"
    }
  },
  "productid": "72426-118_75423e10-bf22-4ef2-81de-fa6451541020",
  "productndc": "72426-118",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211616",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "180MG",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEMPEDOIC ACID",
  "proprietary_name": "Nexletol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211616",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bempedoic Acid",
  "start_marketing_date": "20200306",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code C10AX15.

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