Medicine
Spiriva HandiHaler 18 mcg inhalation capsule
Spiriva HandiHaler 18 mcg inhalation capsule is a prescription medicine containing Tiotropium for inhalation, oral use, marketed by Boehringer Ingelheim Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68° to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tiotropium
- Brand
- Spiriva HandiHaler
- Strength
- 18 mcg
- Dosage form
- Inhalation capsule
- Route
- Inhalation, oral
- Packs
- 3 blister pack, 9 blister pack, 1 blister pack and 2 more
- Marketing authorisation holder
- Boehringer Ingelheim Pharmaceuticals
- Manufacturers
- Boehringer Ingelheim PharmaceuticalsA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68° to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not store SPIRIVA capsules in the HANDIHALER device.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03BB04 Tiotropium
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 October 2005
- Identifiers
- RxCUI 485032, 580261DailyMed set ID c6343458-617b-41ed-8e96-763e91dc8e90, 820839ef-e53d-47e8-a3b9-d911ff92e6a9, ba462261-734a-4e9f-a5c0-5c676bc56a2eNDC 50090-7645, 0597-0075, 50090-4248Application NDA021395
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 0597-0075-41 | Boehringer Ingelheim Pharmaceuticals | 11 October 2005 |
| 9 blister pack in 1 carton / 10 capsule in 1 blister pack | 0597-0075-47 | Boehringer Ingelheim Pharmaceuticals | 11 October 2005 |
| 1 blister pack in 1 carton / 5 capsule in 1 blister pack | 0597-0075-75 | Boehringer Ingelheim Pharmaceuticals | 11 October 2005 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 50090-4248-0 | A-S Medication Solutions | 2 April 2019 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 50090-7645-0 | A-S Medication Solutions | 29 August 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 January 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tiotropium 18 mcg inhalation capsule.
Other strengths and forms of Tiotropium
Clinical summary
Tiotropium is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, among other approved uses. MedsAcross supplies Tiotropium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TiotropiumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Spiriva HandiHaler prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Spiriva HandiHaler 18 mcg inhalation capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.