Active ingredient
Suvorexant
4 finished FDA listings contain Suvorexant as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SUVOREXANT
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 15 mg/1 · 20 mg/1 · 5 mg/1
- Brand names in FDA listings
- Belsomra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1547099
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 204569 | MERCK SHARP DOHME | 2014-08-13 | 4 |
Official labeling on DailyMed
- BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] · version 21 · 2025-03-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.