Active ingredient
Trihexyphenidyl
17 finished FDA listings contain Trihexyphenidyl as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Dosage forms
- Solution, Syrup, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 2 mg/1 · 2 mg/5ml · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10811
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 084363 | WATSON LABS | 1974-11-26 | 2 |
| ANDA 084364 | WATSON LABS | 1974-12-06 | 3 |
| ANDA 040177 | PHARM ASSOC | 1997-04-17 | 1 |
| ANDA 040254 | NOVITIUM PHARMA | 1998-12-24 | 6 |
| ANDA 040251 | CHARTWELL RX | 1999-09-27 | 2 |
| ANDA 091630 | NATCO PHARMA LTD | 2010-11-17 | 3 |
Official labeling on DailyMed
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 13 · 2026-07-24
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 13 · 2026-07-24
- TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC] · version 1 · 2026-07-20
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 17 · 2026-07-13
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 13 · 2026-07-13
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 16 · 2026-07-06
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [BIONPHARMA INC.] · version 3 · 2025-07-04
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] · version 10 · 2025-01-16
- TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 8 · 2024-11-21
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.] · version 6 · 2023-09-27
- TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [AKORN] · version 9 · 2022-06-23
- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NATCO PHARMA LIMITED] · version 2 · 2019-11-01
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.