United States· US:0597-0155_79996212-633b-464e-9967-834039fb13a4
Stiolto Respimat
A medicinal product containing tiotropium bromide monohydrate; olodaterol hydrochloride, 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.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE
- 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 · 6
- ndc1105970155281 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970155611 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE
- ndc1105970155701 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGE
- ndc110597-0155-28
- ndc110597-0155-61
- ndc110597-0155-70
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tiotropium bromide monohydrate; olodaterol hydrochloride in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSPIOLTO RESPIMATBoehringer Ingelheim International GmbH, Ingelheim am Rhein
- NetherlandsSpiolto Respimat 2,5 microgram/2,5 microgram, inhalatieoplossingBoehringer Ingelheim International GmbH
- IrelandSpiolto Respimat 2.5 microgram/2.5 microgram, inhalation solutionIMED Healthcare Ltd.,
- SpainSPIOLTO RESPIMAT 2,5 MICROGRAMOS / 2,5 MICROGRAMOS SOLUCION PARA INHALACIONBoehringer Ingelheim International Gmbh
- United KingdomSpiolto Respimat 2.5micrograms/dose / 2.5micrograms/dose inhalation solution cartridge with deviceBoehringer Ingelheim Ltd
- FinlandInspiolto RespimatBoehringer Ingelheim International GmbH
- SwitzerlandSpiolto Respimat 2.5 mcg / 2.5 mcg, Lösung zur Inhalation (wiederverwendbar)Boehringer Ingelheim (Schweiz) GmbH
- PolandSpiolto RespimatBoehringer Ingelheim International GmbH
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Spiolto Respimat, Yanimo Respimat
- Belgium · Spiolto Respimat, Yanimo Respimat
- Bulgaria · Спиолто Респимат, Янимо Респимат
- Cyprus · Spiolto Respimat, Yanimo Respimat
- Czechia · Spiolto Respimat
- Germany · Spiolto Respimat, Yanimo Respimat
- Denmark · Spiolto Respimat
- Estonia · Spiolto Respimat
- Spain · Spiolto Respimat, Yanimo Respimat
- Finland · Inspiolto Respimat, Yanimo Respimat
- France · Spiolto Respimat
- United Kingdom (Northern Ireland) · Spiolto Respimat
- Greece · Spiolto Respimat, Yanimo Respimat
- Croatia · Spiolto Respimat
- Hungary · Spiolto Respimat
- Ireland · Spiolto Respimat
- Iceland · Spiolto Respimat
- Italy · Spiolto Respimat
- Liechtenstein · Spiolto Respimat, Yanimo Respimat
- Lithuania · Spiolto Respimat
- Luxembourg · Spiolto Respimat, Yanimo Respimat
- Latvia · Spiolto Respimat
- Malta · Spiolto Respimat
- Netherlands · Spiolto Respimat, Yanimo Respimat
- Norway · Spiolto Respimat
- Poland · Spiolto Respimat, Yanimo Respimat
- Portugal · Spiolto Respimat, Yanimo Respimat
- Romania · Spiolto Respimat
- Sweden · Spiolto Respimat, Yanimo Respimat
- Slovenia · Spiolto Respimat
- Slovakia · Spiolto 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/2f679cba-93ed-48d3-8d97-b0a6ea976a58 GET /v1/drugs/2f679cba-93ed-48d3-8d97-b0a6ea976a58?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; 2.736",
"substance": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
"productndc": "0597-0155",
"dosage_form": "SPRAY, METERED",
"dea_schedule": null,
"strength_unit": "ug/1; ug/1",
"application_number": "NDA206756",
"marketing_category": "NDA"
}See everything about tiotropium bromide monohydrate; olodaterol hydrochloride.
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.