Active ingredient
Thioridazine
20 finished FDA listings contain Thioridazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- THIORIDAZINE HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 10 mg/1 · 100 mg/1 · 25 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10502
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 088131 | CHARTWELL RX | 1983-08-30 | 1 |
| ANDA 088133 | CHARTWELL RX | 1983-08-30 | 1 |
| ANDA 088134 | CHARTWELL RX | 1983-08-30 | 1 |
| ANDA 088004 | MYLAN | 1983-11-18 | 12 |
| ANDA 088135 | CHARTWELL RX | 1984-11-20 | 1 |
| ANDA 089953 | SUN PHARM INDUSTRIES | 1988-10-07 | 4 |
Official labeling on DailyMed
- THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH LLC] · version 2 · 2026-03-04
- THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] · version 15 · 2025-11-17
- THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC] · version 1 · 2025-02-24
- THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 15 · 2025-02-14
- THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 7 · 2017-11-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.