Active ingredient
Tiotropium
6 finished FDA listings contain Tiotropium as their only active ingredient; 1 combination products also contain it.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE ANHYDROUS, TIOTROPIUM BROMIDE MONOHYDRATE
- Dosage forms
- Capsule, Spray, Metered
- Routes
- Oral, Respiratory (Inhalation)
- Manufacturers / labelers
- 3
- Strengths listed
- 1.562 ug/1 · 18 ug/1 · 3.124 ug/1
- Brand names in FDA listings
- Spiriva Handihaler, Spiriva Respimat
Official drug information
Source coverage for Tiotropium:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 69120
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 021395
- Sponsor
- BOEHRINGER INGELHEIM
- Original approval
- 2004-01-30
- Listings
- 3
- Application
- NDA 021936
- Sponsor
- BOEHRINGER INGELHEIM
- Original approval
- 2014-09-24
- Listings
- 1
- Application
- NDA 207070
- Sponsor
- BOEHRINGER INGELHEIM
- Original approval
- 2015-09-15
- Listings
- 1
- Application
- ANDA 211287
- Sponsor
- LUPIN
- Original approval
- 2023-06-20
- Listings
- 1
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021395 | BOEHRINGER INGELHEIM | 2004-01-30 | 3 |
| NDA 021936 | BOEHRINGER INGELHEIM | 2014-09-24 | 1 |
| NDA 207070 | BOEHRINGER INGELHEIM | 2015-09-15 | 1 |
| ANDA 211287 | LUPIN | 2023-06-20 | 1 |
Official labeling on DailyMed
- SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 16 · 2026-08-19
- SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 28 · 2025-11-20
- TIOTROPIUM BROMIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] · version 9 · 2025-11-17
- SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS] · version 1 · 2025-09-03
- SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS] · version 3 · 2023-02-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.