Active ingredient
Vortioxetine
7 finished FDA listings contain Vortioxetine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VORTIOXETINE, VORTIOXETINE HYDROBROMIDE, VORTIOXETINE HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/1 · 20 mg/1 · 5 mg/1
- Brand names in FDA listings
- Trintellix
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1455099
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 204447 | TAKEDA PHARMS USA | 2013-09-30 | 7 |
Official labeling on DailyMed
- TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-04-27
- TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 2 · 2026-04-27
- TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 21 · 2026-02-23
- TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] · version 18 · 2025-03-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.