United States· US:67046-2060_583a9499-97c0-2ebf-e063-6394a90a35af
Montelukast
A montelukast product containing montelukast sodium, registered in United States by Coupler LLC. The same ATC class is registered in 19 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
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
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MONTELUKAST SODIUM
- Manufacturer
- Coupler LLC
- 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 · 1
- ndc1167046-2060-3
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.
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.
- United KingdomMontelukast 10mg tabletsMedihealth (Northern) Ltd
- CanadaACH-MONTELUKASTACCORD HEALTHCARE INC
- FinlandMontelukast OrionOrion Corporation
- IrelandMontelukast Pinewood 10 mg TabletsPinewood Laboratories Limited
- NetherlandsMontelukast OPKO 10 mg tablettenOPKO Health Spain S.L.U.
- PolandOrilukastOrion Corporation
- SpainMONTELUKAST OPKO 10 MG COMPRIMIDOS EFGOpko Health Spain S.L.U.
- CzechiaCASTISPIRSandoz s.r.o., Praha
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/41fc2237-db4d-466f-8edf-d976cc31eeb1 GET /v1/drugs/41fc2237-db4d-466f-8edf-d976cc31eeb1?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": "67046-2060",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA203366",
"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.