United States· US:70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a
Tudorza Pressair
A medicinal product containing aclidinium bromide, registered in United States by Covis Pharma US, Inc.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ACLIDINIUM BROMIDE
- Manufacturer
- Covis Pharma US, 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 · 6
- ndc1170515002011 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
- ndc1170515002021 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
- ndc1170515002031 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
- ndc1170515-002-01
- ndc1170515-002-02
- ndc1170515-002-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Aclidinium bromide in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAclidinium bromide 375micrograms/dose dry powder inhalerJ M McGill Ltd
- CzechiaBRETARIS GENUAIRCovis Pharma Europe B.V., Amsterdam
- BelgiumBretaris Genuair 322 µgCovis Pharma Europe
- FinlandBretaris GenuairCOVIS PHARMA EUROPE B.V.
- IrelandBretaris Genuair 322 micrograms inhalation powderCovis Pharma Europe B.V.
- IcelandBretaris GenuairCovis Pharma Europe B.V.
- ItalyBRETARIS GENUAIR*polv inal 1 flacone 60 dosi 322 mcgCOVIS PHARMA EUROPE BV
- NetherlandsBretaris Genuair 322 microgram inhalatiepoederCovis Pharma Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Bretaris Genuair, Eklira Genuair
- Liechtenstein · Bretaris Genuair, Eklira Genuair
- Norway · Bretaris Genuair, Eklira Genuair
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/a3c3637d-12f4-4fa8-9308-d68c93394612 GET /v1/drugs/a3c3637d-12f4-4fa8-9308-d68c93394612?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": "400",
"substance": "ACLIDINIUM BROMIDE",
"productndc": "70515-002",
"dosage_form": "POWDER, METERED",
"dea_schedule": null,
"strength_unit": "ug/1",
"application_number": "NDA202450",
"marketing_category": "NDA"
}See everything about aclidinium bromide.
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.