Quick answers
- What is Tolcapone used for?
- The FDA-approved label (Tasmar, Bausch Health US LLC, October 2, 2020) says: “INDICATIONS: TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tolcapone have a boxed warning?
- Yes. The FDA label for Tasmar has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tolcapone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tolcapone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tolcapone?
- 3 companies list prescription products of Tolcapone in the FDA NDC Directory, including Oceanside Pharmaceuticals, Bausch Health US, LLC and Ingenus Pharmaceuticals, LLC.
What Tolcapone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS: TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are …
— FDA label: Tasmar, Bausch Health US LLC, effective October 2, 2020. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Tasmar |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Oceanside Pharmaceuticals1 product
- Bausch Health US, LLC1 product
- Ingenus Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020697 TASMAR | Bausch | January 29, 1998 | 12, latest September 30, 2014 2014: Manufacturing (CMC) · 2013: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (1)
- ANDA208937Ingenus Pharms LLC · August 7, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 153655, 200220 |
|---|---|
| SPL set ID of the quoted label | a0e47a9d-78e7-4523-983a-aa259f221736 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA020697, 1 ANDA |
| Active ingredients (FDA) | TOLCAPONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tasmar, Bausch Health US LLC, effective October 2, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →