Active ingredient
Maralixibat
6 finished FDA listings contain Maralixibat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MARALIXIBAT, MARALIXIBAT CHLORIDE
- Dosage forms
- Solution, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 15 mg/1 · 19 mg/ml · 20 mg/1 · 30 mg/1 · 9.5 mg/ml
- Brand names in FDA listings
- Livmarli
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2571074
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 214662 | MIRUM | 2021-09-29 | 2 |
| NDA 219485 | MIRUM | 2025-04-10 | 4 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.