Livmarli

Orange BookUNIISPLATC A05AX04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMirum Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA05AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7937823030
1 BOTTLE in 1 CARTON (79378-230-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

V78M04F0XC

MARALIXIBAT CHLORIDE

RxCUI 2571073

Orange Book

N219485

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "V78M04F0XC",
    "rxcui": "2571073",
    "inchikey": "POMVPJBWDDJCMP-RUKDTIIFSA-M",
    "display_name": "MARALIXIBAT CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "64000394-1ef6-4e76-8ba8-11f25ba1b167": {
      "match": "brand_token",
      "title": "LIVMARLI (MARALIXIBAT CHLORIDE) SOLUTION LIVMARLI (MARALIXIBAT CHLORIDE) TABLET [MIRUM PHARMACEUTICALS INC.]",
      "spl_version": "11",
      "published_date": "2025-04-28"
    }
  },
  "productid": "79378-230_560d193b-5be5-4799-adfc-f7b36dddd434",
  "productndc": "79378-230",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219485",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Apr 10, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Apr 10, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Apr 10, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "004",
        "approval_date": "Apr 10, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MARALIXIBAT CHLORIDE",
  "proprietary_name": "Livmarli",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219485",
  "marketing_category": "NDA",
  "nonproprietary_name": "maralixibat chloride",
  "start_marketing_date": "20250410",
  "active_numerator_strength": "30"
}

Related drugs

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