United States· US:64896-403_550f6797-b388-4ceb-885c-ef56f48ae06c
ONGENTYS
A opicapone product containing opicapone, registered in United States by Amneal Pharmaceuticals LLC. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Opicapone is registered in 14 of 19 countries.
Countries holding a registration under ATC N04BX04 (opicapone), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 10 of them publish a price we can compare per daily dose
Opicapone · ATC N04BX04
14 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of opicapone costs, country by country.
Normalised to the WHO defined daily dose (50 mg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Opicapone · price per daily dose (50 mg)
USD · FX 28 Sept 2026
- CH Switzerland$6.01
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- OPICAPONE
- Manufacturer
- Amneal Pharmaceuticals LLC
- Country
- United States (US)
- ATC code
- N04BX04
- ATC class
- Opicapone
- Defined daily dose
- 50 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1164896-403-01
- ndc1164896-403-02
- ndc1164896-403-03
- ndc11648964030130 CAPSULE in 1 BOTTLE (64896-403-01)
- ndc1164896403027 CAPSULE in 1 BOTTLE (64896-403-02)
- ndc11648964030330 CAPSULE in 1 BOTTLE (64896-403-03)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
69 interactions on record for opicapone.
Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Opicapone · interactions on record
69 records
- 2 severe
- 67 moderate
Most severe, free to view
- ProcarbazineL01XB01severe
- Methylthioninium chlorideV03AB17severe
- EpinephrineA01AD01moderate
- MetoclopramideA03FA01moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Opicapone in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainONGENTYS 50 MG CAPSULAS DURASBial Portela & Ca S.A.
- CzechiaONGENTYSBIAL - Portela & Ca., SA, S. Mamede do Coronado
- FinlandOngentysParanova Oy
- SwitzerlandOngentys 50 mg, gélulesBial SA
- BelgiumOngentys 50 mgBIAL - Portela & Cª
- United KingdomOngentys 50mg capsulesPharmaram Ltd
- PolandOngentysBIAL - Portela & Ca. SA
- IrelandOngentys 50 mg hard capsulesBIAL-Portela & Ca, S.A.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ongentys
- Liechtenstein · Ongentys
- Norway · Ongentys
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/2b9796cf-89a1-4cd4-a8bf-52a45daf1ff5 GET /v1/drugs/2b9796cf-89a1-4cd4-a8bf-52a45daf1ff5?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "50",
"substance": "OPICAPONE",
"productndc": "64896-403",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA212489",
"marketing_category": "NDA"
}See everything about opicapone.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.