Active ingredient
Gepirone
4 finished FDA listings contain Gepirone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GEPIRONE HYDROCHLORIDE
- Dosage forms
- Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 18.2 mg/1 · 36.3 mg/1 · 54.5 mg/1 · 72.6 mg/1
- Brand names in FDA listings
- Exxua
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2672253
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 021164 | FABRE KRAMER | 2023-09-22 | 4 |
Official labeling on DailyMed
- EXXUA (GEPIRONE) TABLET, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC] · version 3 · 2026-07-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.