Active ingredient
Zuranolone
3 finished FDA listings contain Zuranolone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ZURANOLONE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 20 mg/1 · 25 mg/1 · 30 mg/1
- Brand names in FDA listings
- Zurzuvae
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2669905
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 217369 | BIOGEN | 2023-08-04 | 3 |
Official labeling on DailyMed
- ZURZUVAE (ZURANOLONE) CAPSULE [BIOGEN MA INC.] · version 18 · 2026-06-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.