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United States· US:78206-125_74079d8a-85a1-4736-8486-76624af02194

Dulera

A formoterol and mometasone product containing formoterol fumarate; mometasone furoate, registered in United States by Organon LLC. The same ATC class is registered in 2 of our 19 countries.

ATC R03AK09US 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…normalisedDuleraATCR03AK09REGISTER NO.US:78206-125_74079d8a…PACKS LISTED4CHECKEDJuly 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about formoterol fumarate; mometasone furoateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Formoterol and mometasone is registered in 2 of 19 countries.

Countries holding a registration under ATC R03AK09 (formoterol and mometasone), each read from that country’s own register.

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

Formoterol and mometasone · ATC R03AK09

2 / 19 countries

  • Canada
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Manufacturer
Organon LLC
Country
United States (US)
ATC code
R03AK09
ATC class
Formoterol and mometasone
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 12, 2026

Packs & prices · 4

  • ndc11
    7820612501
    1 CANISTER in 1 CARTON (78206-125-01) / 120 AEROSOL in 1 CANISTER
  • ndc11
    7820612559
    1 CANISTER in 1 CARTON (78206-125-59) / 120 AEROSOL in 1 CANISTER
  • ndc11
    78206-125-01
  • ndc11
    78206-125-59

Regulatory notes

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

Same medicine, other countries

Formoterol and mometasone in 1 other country

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

All formoterol and mometasone products

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/0e1cd974-8588-4ddf-b0a0-d9cf7bd606cb
GET /v1/drugs/0e1cd974-8588-4ddf-b0a0-d9cf7bd606cb?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": "RESPIRATORY (INHALATION)",
  "source": "ndc",
  "strength": "5; 50",
  "substance": "FORMOTEROL FUMARATE; MOMETASONE FUROATE",
  "productndc": "78206-125",
  "dosage_form": "AEROSOL",
  "dea_schedule": null,
  "strength_unit": "ug/1; ug/1",
  "application_number": "NDA022518",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about formoterol and mometasone.

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.

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