United States· US:0597-0100_e44a3eea-f679-45fc-994a-0e960975b36b

Spiriva Respimat

A medicinal product containing tiotropium bromide anhydrous, registered in United States by Boehringer Ingelheim Pharmaceuticals, Inc..

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSpiriva RespimatATC—REGISTER NO.US:0597-0100_e44a3eea…PACKS LISTED3CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TIOTROPIUM BROMIDE ANHYDROUS
Manufacturer
Boehringer Ingelheim 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 · 3

  • ndc11
    0597-0100-28
  • ndc11
    0597-0100-51
  • ndc11
    0597-0100-61

Regulatory notes

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

Same medicine, other countries

Tiotropium bromide anhydrous 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 anhydrous 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/ccd28112-a293-4319-b134-f1676d339e83
GET /v1/drugs/ccd28112-a293-4319-b134-f1676d339e83?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": "3.124",
  "substance": "TIOTROPIUM BROMIDE ANHYDROUS",
  "productndc": "0597-0100",
  "dosage_form": "SPRAY, METERED",
  "dea_schedule": null,
  "strength_unit": "ug/1",
  "application_number": "NDA021936",
  "marketing_category": "NDA"
}

See everything about tiotropium bromide anhydrous.

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.