Back to search

United States· US:31722-727_c503ea71-c663-3cfc-e053-2a95a90a9aaa

montelukast sodium

A montelukast product containing montelukast, registered in United States by Camber Pharmaceuticals, Inc.. 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…normalisedmontelukast sodiumATCR03DC03REGISTER NO.US:31722-727_c503ea71…PACKS LISTED12CHECKEDSeptember 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
Manufacturer
Camber Pharmaceuticals, Inc.
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 · 12

  • ndc11
    3172272701
    100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01)
  • ndc11
    3172272710
    1000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10)
  • ndc11
    3172272730
    30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30)
  • ndc11
    3172272731
    10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31)
  • ndc11
    3172272732
    100 TABLET, CHEWABLE in 1 CARTON (31722-727-32)
  • ndc11
    3172272790
    90 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90)
  • ndc11
    31722-727-01
  • ndc11
    31722-727-10
  • ndc11
    31722-727-30
  • ndc11
    31722-727-31
  • ndc11
    31722-727-32
  • ndc11
    31722-727-90

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/90830941-165b-4cf8-a6c6-0b63c4010387
GET /v1/drugs/90830941-165b-4cf8-a6c6-0b63c4010387?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": "4",
  "substance": "MONTELUKAST",
  "productndc": "31722-727",
  "dosage_form": "TABLET, CHEWABLE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA204093",
  "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.