FDA label
What is Ongentys used for?
Ongentys contains opicapone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.”
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Ongentys, capsule
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (NDA212489). Cross-references to other label sections are left out.
ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Source: DailyMed label, set id a511a531-112e-43f8-a43f-5334b0efe979, version 9, effective October 15, 2025. NDC 64896-402, one of 2 listings for this product.
Questions
What is Ongentys used for?
The FDA label says: “ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.”
What drug class is Ongentys?
FDA lists opicapone in the Catechol-O-Methyltransferase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.