Quick answers
- What is Entacapone used for?
- The FDA-approved label (Entacapone, Sandoz Inc, November 30, 2023) says: “INDICATIONS Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Entacapone have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Entacapone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Entacapone been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 29, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Entacapone?
- 14 companies list prescription products of Entacapone in the FDA NDC Directory, including NCS HealthCare of KY, LLC dba Vangard Labs, Major Pharmaceuticals and Macleods Pharmaceuticals Limited.
What Entacapone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.
— FDA label: Entacapone, Sandoz Inc, effective November 30, 2023. Read the full label on DailyMed →
The FDA has 14 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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 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 | 14 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| entacapone 200 mg tablet | Generic | $0.3318 per tablet |
| entacapone 200 mg tablet, film coated | Generic | $0.3318 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Major Pharmaceuticals1 product
- Macleods Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Limited1 product
- Aurobindo Pharma Limited1 product
- Sandoz Inc1 product
- Ajanta Pharma USA Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
- Lannett Company, Inc.1 product
- AvPAK1 product
- Rising Pharma Holdings, Inc.1 product
- American Health Packaging1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 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 |
|---|---|---|---|
| NDA020796 COMTAN | Orion Pharma | October 19, 1999 | 13, latest February 22, 2016 2016: Labeling · 2015: Manufacturing (CMC) · 2015: Labeling |
Generic approvals (5)
- ANDA203437Aurobindo Pharma Ltd · June 19, 2015
- ANDA207210Macleods Pharms · June 5, 2017
- ANDA205792Ajanta Pharma Ltd · August 31, 2017
- ANDA206669Sunshine · October 3, 2018
- ANDA212601Alembic · January 4, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 29, 2021 · Class II · Terminated · D-0806-2021
Failed Dissolution Specifications
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04 — The Harvard Drug Group
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 317094 |
|---|---|
| SPL set ID of the quoted label | ad4b6d79-efd3-4c43-b4dc-5afdacf939a4 |
| FDA labels (SPL) | 14 |
| FDA applications | NDA020796, 5 ANDA |
| Active ingredients (FDA) | ENTACAPONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Entacapone, Sandoz Inc, effective November 30, 2023; 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 →