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ONGENTYS

Active substance: opicapone

CAPSULE · OPICAPONE 25 mg/1

United StatesActive

Marketing holder: Amneal Pharmaceuticals LLC

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 2
  • Ongentys
    opicapone
    EMEA/H/C/002790
    Bial - Portela Cª, S.A.
  • Ontilyv
    opicapone
    EMEA/H/C/005782
    Bial Portela & Companhia S.A.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-7465-7a9c-94e0-6feecf7adac9,01a12092-49e6-7057-9a0c-9701391f6c66;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
64896-402
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 64896-402 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 64896-402 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 64896-402 · Verified 2026-10-09 · open in source