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United States · US · US:79378-111_560d193b-5be5-4799-adfc-f7b36dddd434
Livmarli
Orange BookUNIISPLATC A05AX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMirum Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA05AX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1179378111011 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
V78M04F0XC
MARALIXIBAT CHLORIDE
RxCUI 2571073
Orange Book
N214662
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": "79378-111_560d193b-5be5-4799-adfc-f7b36dddd434",
"productndc": "79378-111",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214662",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 9.5MG BASE/ML",
"product_no": "001",
"approval_date": "Sep 29, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 19MG BASE/ML",
"product_no": "002",
"approval_date": "Jul 24, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MARALIXIBAT CHLORIDE",
"proprietary_name": "Livmarli",
"active_ingred_unit": "mg/mL",
"application_number": "NDA214662",
"marketing_category": "NDA",
"nonproprietary_name": "maralixibat chloride",
"start_marketing_date": "20240724",
"active_numerator_strength": "19"
}Related drugs
Other records sharing ATC code A05AX04.
- ISLivmarliMirum Pharmaceuticals International B.V.
- ISLivmarliMirum Pharmaceuticals International B.V.
- ISLivmarliMirum Pharmaceuticals International B.V.
- ISLivmarliMirum Pharmaceuticals International B.V.
- ISLivmarliMirum Pharmaceuticals International B.V.
- ISLivmarliMirum Pharmaceuticals International B.V.
- PLLivmarliMirum Pharmaceuticals International B.V.
- DKLivmarliMirum Pharmaceuticals International B.V.
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