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United States · US · US:72426-818_d5525891-2cfc-49bf-a684-5d5628dfb9bc

Nexlizet

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerEsperion Therapeutics, Inc.
CountryUS (United States)
ATC codeC10AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7242681803
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03)
  • ndc11
    7242681899
    7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)

Annotations

UNII (FDA Substance ID)
1EJ6Z6Q368
BEMPEDOIC ACID
RxCUI 2282403
Orange Book
N211617
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": {
    "3fa2108c-0300-47b8-9d34-f762af7c93c6": {
      "match": "brand_token",
      "title": "NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE) TABLET, FILM COATED [ESPERION THERAPEUTICS, INC.]",
      "spl_version": "22",
      "published_date": "2026-01-19"
    }
  },
  "productid": "72426-818_d5525891-2cfc-49bf-a684-5d5628dfb9bc",
  "productndc": "72426-818",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211617",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "180MG;10MG",
        "product_no": "001",
        "approval_date": "Feb 26, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEMPEDOIC ACID; EZETIMIBE",
  "proprietary_name": "Nexlizet",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA211617",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bempedoic Acid and Ezetimibe",
  "start_marketing_date": "20200309",
  "active_numerator_strength": "180; 10"
}

Related drugs

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