United States· US:71610-247_a3c90a47-42cb-44b6-99e0-f027dc45ac2b

Entacapone

A entacapone product containing entacapone, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 18 of our 19 countries.

ATC N04BX02US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedEntacaponeATCN04BX02REGISTER NO.US:71610-247_a3c90a47…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Entacapone is registered in 18 of 19 countries.

Countries holding a registration under ATC N04BX02 (entacapone), 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

Entacapone · ATC N04BX02

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of entacapone costs, country by country.

Normalised to the WHO defined daily dose (1 g), the median price runs from $1.87 in France to $6.60 in Switzerland — a ×3.5 gap.

  • 3 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Entacapone · price per daily dose (1 g)

USD · FX 28 Sept 2026

  • CH Switzerland$6.60
  • IT Italy$6.27
  • FR France$1.87
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ENTACAPONE
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Country
United States (US)
ATC code
N04BX02
ATC class
Entacapone
Defined daily dose
1 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    7161024783
    3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83)
  • ndc11
    71610-247-83

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

110 interactions on record for entacapone.

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

Entacapone · interactions on record

110 records

  • 2 severe
  • 61 moderate
  • 1 minor
  • 46 info

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Entacapone in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All entacapone products

Authorised across Europe · EMA

The same active substance is authorised in 16 EEA countries. Names it is sold under:

  • Cyprus · Encapia
  • Germany · Entacapon Hec
  • Denmark · Entacapone Viatris
  • Spain · Entacapona Viatris, Medapia
  • Finland · Entacapone Orion Pharma
  • France · Entacapone Arrow, Entacapone Viatris
  • United Kingdom (Northern Ireland) · Entacapone, Entacapone Hec
  • Croatia · Entakapon Hec
  • Iceland · Comtan, Comtess
  • Liechtenstein · Comtan, Comtess
  • Lithuania · Medapia
  • Malta · Medapia
  • Netherlands · Encapia, Entacapone Unichem
  • Norway · Comtan, Comtess
  • Portugal · Entacapona Aurobindo, Medapia
  • Sweden · Entacapone Viatris

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/682487b2-d307-4e3a-8d2e-a539db2e00c5
GET /v1/drugs/682487b2-d307-4e3a-8d2e-a539db2e00c5?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": "200",
  "substance": "ENTACAPONE",
  "productndc": "71610-247",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA020796",
  "marketing_category": "NDA AUTHORIZED GENERIC"
}

See everything about entacapone.

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.