Active ingredient
Trifluoperazine
24 finished FDA listings contain Trifluoperazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TRIFLUOPERAZINE HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 1 mg/1 · 10 mg/1 · 2 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10800
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 |
|---|---|---|---|
| ANDA 085786 | SANDOZ | 1981-11-20 | 3 |
| ANDA 085789 | SANDOZ | 1981-11-20 | 3 |
| ANDA 085785 | SANDOZ | 1981-11-20 | 2 |
| ANDA 085788 | SANDOZ | 1981-11-20 | 2 |
| ANDA 040209 | MYLAN | 1997-07-07 | 14 |
Official labeling on DailyMed
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-07-01
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH LLC] · version 3 · 2026-05-06
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 12 · 2026-02-02
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 12 · 2026-02-02
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] · version 11 · 2025-07-24
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 16 · 2025-04-07
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC.] · version 7 · 2025-02-14
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2024-10-21
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2024-04-08
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2024-04-08
- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2024-04-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.