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United States· US:13668-542_cf99b6a6-818b-4991-b85b-63e2eefbf4fd

Macitentan

A macitentan product containing macitentan, registered in United States by Torrent Pharmaceuticals Limited. The same ATC class is registered in 17 of our 19 countries.

ATC C02KX04

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMacitentanATCC02KX04REGISTER NO.US:13668-542_cf99b6a6…PACKS LISTED3CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about macitentanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Macitentan is registered in 17 of 19 countries.

Countries holding a registration under ATC C02KX04 (macitentan), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search macitentan products by name

Macitentan · ATC C02KX04

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • 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 macitentan costs, country by country.

Normalised to the WHO defined daily dose (10 mg), so markets compare like for like.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Macitentan · price per daily dose (10 mg)

USD · FX 28 Sept 2026

  • IT Italy$161.10
  • CH Switzerland$108.22
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
MACITENTAN
Manufacturer
Torrent Pharmaceuticals Limited
Country
United States (US)
ATC code
C02KX04
ATC class
Macitentan
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 3

  • ndc11
    13668-542-05
  • ndc11
    13668-542-30
  • ndc11
    13668-542-90

Regulatory notes

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

Interactions

83 interactions on record for macitentan.

Graded by severity as the source publishes them — 17 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
Check macitentan against other medicinesHow interaction checks work

Macitentan · interactions on record

83 records

  • 17 severe
  • 65 moderate
  • 1 minor

Most severe, free to view

  • KetoconazoleH02CA03severe
  • ErythromycinJ01FA01severe
  • ClarithromycinJ01FA09severe
  • KetoconazoleJ02AB02severe
  • 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

Macitentan in 15 other countries

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

All macitentan products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Macepulan, Macicon
  • Belgium · Macitentan Ab, Macitentan Eg
  • Bulgaria · Мацитентан Зентива, Мацитентан Тева
  • Cyprus · Macitentan Sandoz
  • Czechia · Macitentan Olpha, Macitentan Teva
  • Germany · Macitentan 1 A Pharma, Macitentan Abdi
  • Denmark · Macitentan "sandoz", Macitentan Devatis
  • Estonia · Macitentan Norameda, Macitentan Olpha
  • Spain · Macitentan Dr. Reddys, Macitentán Glenmark
  • Finland · Macitentan Devatis, Macitentan Glenmark
  • France · Macitentan Olpha, Opsaren
  • United Kingdom (Northern Ireland) · Macitentan, Macitentan Accord Healthcare
  • Greece · Macitentan Bioars, Macitentan Pharmapath
  • Croatia · Jesoxade, Macitentan Teva
  • Hungary · Cidevia, Macepulan
  • Ireland · Macitentan Abdi, Macitentan Clonmel
  • Iceland · Macitentan Accord, Macitentan Accordpharma
  • Italy · Macitentan Abdi, Macitentan Aurobindo
  • Liechtenstein · Macitentan Accord, Macitentan Accordpharma
  • Lithuania · Macitentan Norameda, Macitentan Olpha
  • Luxembourg · Macitentan Ab, Macitentan Eg
  • Latvia · Macitentan Norameda, Macitentan Olpha
  • Malta · Cidevia, Macitentan Clonmel
  • Netherlands · Macitentan Aurobindo, Macitentan Cf
  • Norway · Macitentan Accord, Macitentan Accordpharma
  • Poland · Jesoxade, Macitentan Olpha
  • Portugal · Macitentan Onkogen, Macitentano
  • Romania · Jesoxade, Macitentan Stada
  • Sweden · Macitentan Amarox, Macitentan Bioglan
  • Slovakia · Macitentan Olpha, Macitentan Stada

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/1e6ab4ba-9abf-4cb8-b4b8-fe4a0ce7723f
GET /v1/drugs/1e6ab4ba-9abf-4cb8-b4b8-fe4a0ce7723f?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": "10",
  "substance": "MACITENTAN",
  "productndc": "13668-542",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA211107",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about macitentan.

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.

Try it freeOpen in the console