United States· US:50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76

Spiriva

A medicinal product containing tiotropium bromide monohydrate, registered in United States by A-S Medication Solutions.

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: TIOTROPIUM BROMIDE MONOHYDRATE
Manufacturer: A-S Medication Solutions
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 · 2

ndc11
50090-4248-0
ndc11
5009042480
3 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACK

Regulatory notes

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

Same medicine, other countries

Tiotropium bromide monohydrate in 18 other countries

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

All tiotropium bromide monohydrate products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

Austria · Braltus, Spiriva
Belgium · Spiriva, Spiriva Respimat
Bulgaria · Бралтус, Плубром
Cyprus · Spiriva, Spiriva Respimat
Czechia · Gartior, Spiriva
Germany · Acopair, Braltus
Denmark · Braltus, Spiriva
Estonia · Spiriva Respimat
Spain · Braltus, Gregal
Finland · Spiriva, Spiriva Respimat
France · Spiriva, Spiriva Respimat
United Kingdom (Northern Ireland) · Abtio, Acopair
Greece · Spiriva, Spiriva Respimat
Croatia · Acopair, Braltus
Hungary · Braltus, Ontipria
Ireland · Braltus, Spiriva
Iceland · Braltus, Spiriva
Italy · Scinorus, Sirkava
Liechtenstein · Spiriva, Spiriva Respimat
Lithuania · Spiriva, Spiriva Respimat
Luxembourg · Spiriva, Spiriva Respimat
Latvia · Spiriva, Spiriva Respimat
Malta · Spiriva, Spiriva Respimat
Netherlands · Scinorus, Spiriva
Norway · Braltus, Spiriva
Poland · Braltus, Gartior
Portugal · Braltus, Brometo De Tiotrópio Stada
Romania · Dilochob, Gregal
Sweden · Braltus, Sirkava
Slovenia · Spiriva, Spiriva Respimat
Slovakia · Spiriva, Spiriva Respimat

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/f410bb6b-5c40-49b8-85bf-e9d3649daa76
GET /v1/drugs/f410bb6b-5c40-49b8-85bf-e9d3649daa76?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; RESPIRATORY (INHALATION)",
  "source": "ndc",
  "strength": "18",
  "substance": "TIOTROPIUM BROMIDE MONOHYDRATE",
  "productndc": "50090-4248",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "ug/1",
  "application_number": "NDA021395",
  "marketing_category": "NDA"
}

API reference MCP server Plans

See everything about tiotropium bromide monohydrate.

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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