United States· US:78206-126_8acf5435-9cbf-4991-b7ef-5e5e7d61220a
Dulera
A formoterol and mometasone product containing mometasone furoate; formoterol fumarate, registered in United States by Organon LLC. The same ATC class is registered in 2 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
Formoterol and mometasone · ATC R03AK09
2 / 19 countries
- Canada
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MOMETASONE FUROATE; FORMOTEROL FUMARATE
- 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
- September 27, 2026
Packs & prices · 2
- ndc1178206-126-02
- ndc1178206-126-01
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.
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/f63e1ef2-38a7-4acd-9414-8f705c9a822a GET /v1/drugs/f63e1ef2-38a7-4acd-9414-8f705c9a822a?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": "200; 5",
"substance": "MOMETASONE FUROATE; FORMOTEROL FUMARATE",
"productndc": "78206-126",
"dosage_form": "AEROSOL",
"dea_schedule": null,
"strength_unit": "ug/1; ug/1",
"application_number": "NDA022518",
"marketing_category": "NDA"
}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.