United States· US:50090-6108_eeb0e0ae-31b8-4954-ac31-de5c082b18eb

Montelukast

A montelukast product containing montelukast sodium, registered in United States by A-S Medication Solutions. The same ATC class is registered in 19 of our 19 countries.

ATC R03DC03US 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…normalisedMontelukastATCR03DC03REGISTER NO.US:50090-6108_eeb0e0a…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Montelukast is registered in 19 of 19 countries.

Countries holding a registration under ATC R03DC03 (montelukast), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 11 of them publish a price we can compare per daily dose

Montelukast · ATC R03DC03

19 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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 montelukast costs, country by country.

Normalised to the WHO defined daily dose (10 mg), the median price runs from $0.59 in Italy to $1.71 in Spain — a ×2.9 gap.

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

Montelukast · price per daily dose (10 mg)

USD · FX 28 Sept 2026

  • ES Spain$1.71
  • CH Switzerland$1.41
  • FR France$0.71
  • IT Italy$0.59
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
MONTELUKAST SODIUM
Manufacturer
A-S Medication Solutions
Country
United States (US)
ATC code
R03DC03
ATC class
Montelukast
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 · 4

  • ndc11
    5009061080
    30 TABLET, FILM COATED in 1 BOTTLE (50090-6108-0)
  • ndc11
    5009061081
    90 TABLET, FILM COATED in 1 BOTTLE (50090-6108-1)
  • ndc11
    50090-6108-0
  • ndc11
    50090-6108-1

Regulatory notes

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

Interactions

565 interactions on record for montelukast.

Graded by severity as the source publishes them — 101 moderate. 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

Montelukast · interactions on record

565 records

  • 101 moderate
  • 464 info

Most severe, free to view

  • MiconazoleA07AC01moderate
  • TroglitazoneA10BG01moderate
  • NateglinideA10BX03moderate
  • NitisinoneA16AX04moderate
  • 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

Montelukast in 16 other countries

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

All montelukast products

Authorised across Europe · EMA

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

  • Austria · Lanair, Montelukast +pharma
  • Belgium · Montelukast Ab, Montelukast Eg
  • Bulgaria · Eфира, Moнтелукаст Акорд
  • Cyprus · Modulair, Montelukast Krka
  • Czechia · Castispir, Monkasta
  • Germany · Monkasta, Montelair Hexal
  • Denmark · Montelukast "sandoz", Montelukast Accord Healthcare
  • Estonia · Monkasta, Montelukast Teva
  • Spain · Monkasta, Montelukast Accord
  • Finland · Montelukast, Montelukast Accord
  • France · Montelukast Accord, Montelukast Accord Healthcare
  • United Kingdom (Northern Ireland) · Montelukast, Montelukast for Children From 6 To 14 Years Accord Healthcare
  • Greece · Apilone, Ascolin
  • Croatia · Melarth, Monkasta
  • Hungary · Eonic, Monalux
  • Ireland · Montelair, Montelukast
  • Iceland · Montelukast Alvogen, Singulair
  • Italy · Aleast Per Bambini Da 2 A 5 Anni, Aleast Per Bambini Da 6 A 14 Anni
  • Lithuania · Monkasta
  • Luxembourg · Montelukast Eurogenerics, Montelukast Ratiopharm
  • Latvia · Monkasta
  • Malta · Actamone, Monkasta
  • Netherlands · Montelukast Accord, Montelukast Amarox
  • Norway · Montelukast Krka, Montelukast Sandoz
  • Poland · Asmenol, Astmodil
  • Portugal · Montelucaste Accord, Montelucaste Alter
  • Romania · Monkasta, Montelukast Arena
  • Sweden · Montelukast Accord, Montelukast Amarox
  • Slovenia · Monkasta, Singulair
  • Slovakia · Astmasan, Belokast

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/c07def61-0f06-4f3e-9004-4fe792ee5a27
GET /v1/drugs/c07def61-0f06-4f3e-9004-4fe792ee5a27?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": "MONTELUKAST SODIUM",
  "productndc": "50090-6108",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA202843",
  "marketing_category": "ANDA"
}

See everything about montelukast.

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.