Active ingredient
Tolcapone
3 finished FDA listings contain Tolcapone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOLCAPONE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 100 mg/1
- Brand names in FDA listings
- Tasmar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 72937
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 020697 | BAUSCH | 1998-01-29 | 2 |
| ANDA 208937 | INGENUS PHARMS LLC | 2018-08-07 | 1 |
Official labeling on DailyMed
- TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] · version 7 · 2021-01-06
- TASMAR (TOLCAPONE) TABLET, FILM COATED [BAUSCH HEALTH US LLC] · version 13 · 2021-01-05
- TOLCAPONE TABLET [INGENUS PHARMACEUTICALS, LLC] · version 5 · 2019-09-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.