United States· US:0378-1631_db19667d-88cd-47ab-adb5-894959822801

FORMOTEROL FUMARATE

A medicinal product containing formoterol fumarate, registered in United States by Mylan Pharmaceuticals Inc..

US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: FORMOTEROL FUMARATE
Manufacturer: Mylan Pharmaceuticals Inc.
Country: United States (US)
ATC code: —
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 27, 2026

Packs & prices · 4

ndc11
0378163191
60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
ndc11
0378163193
30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL
ndc11
0378-1631-91
ndc11
0378-1631-93

Regulatory notes

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

Same medicine, other countries

Formoterol fumarate in 16 other countries

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

All formoterol fumarate products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

Austria · Forair, Novolizer Formoterol Meda
Belgium · Foradil, Formagal
Cyprus · Bronchovent, Broncoteril
Czechia · Atimos, Foradil
Germany · Atifor, Foradil P
Denmark · Chemoterol, Foradil
Estonia · Atimos, Fomeda Easyhaler
Spain · Broncoral Neo, Foradil Aerolizer
Finland · Formaxa, Formoterol Easyhaler
France · Asmelor Novolizer, Foradil
United Kingdom (Northern Ireland) · Atimos Modulite, Formoterol Easyhaler Orion Corporation
Greece · Broncoteril, Edufil
Hungary · Atimos, Chemoterol
Ireland · Formoterol, Oxis Turbohaler
Iceland · Oxis Turbuhaler
Italy · Atimos, Foradil
Lithuania · Fomeda Easyhaler, Foradil Aerolizer
Luxembourg · Formagal, Novolizer
Latvia · Atimos, Fomeda Easyhaler
Malta · Oxis Turbohaler
Netherlands · Atimos, Formoterol All-Gen Pharmaceuticals & Generics
Norway · Oxis Turbuhaler
Poland · Atimos, Foradil
Portugal · Atimos, Foradil
Romania · Atimos
Sweden · Fenorol, Formatris Novolizer
Slovenia · Atimos, Oxis Turbuhaler
Slovakia · Atimos, Formano

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/cad61bc6-945b-40c2-ba08-677bd512dbb9
GET /v1/drugs/cad61bc6-945b-40c2-ba08-677bd512dbb9?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": "20",
  "substance": "FORMOTEROL FUMARATE",
  "productndc": "0378-1631",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "ug/2mL",
  "application_number": "NDA022007",
  "marketing_category": "NDA AUTHORIZED GENERIC"
}

API reference MCP server Plans

See everything about formoterol fumarate.

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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