Active ingredient
Protriptyline
4 finished FDA listings contain Protriptyline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROTRIPTYLINE HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8886
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 090462 | SIGMAPHARM LABS LLC | 2010-05-03 | 2 |
| ANDA 202220 | EPIC PHARMA LLC | 2012-11-19 | 2 |
Official labeling on DailyMed
- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] · version 10 · 2023-12-21
- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SIGMAPHARM LABORATORIES, LLC] · version 2 · 2023-01-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.