Active ingredient
Berotralstat
6 finished FDA listings contain Berotralstat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BEROTRALSTAT, BEROTRALSTAT DIHYDROCHLORIDE, BEROTRALSTAT HYDROCHLORIDE
- Dosage forms
- Capsule, Pellet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 108 mg/1 · 110 mg/1 · 132 mg/1 · 150 mg/1 · 72 mg/1 · 96 mg/1
- Brand names in FDA listings
- Orladeyo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2467540
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 214094 | BIOCRYST | 2020-12-03 | 2 |
| NDA 219776 | BIOCRYST | 2025-12-11 | 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.