Quick answers
- What is Tiotropium used for?
- The FDA-approved label (Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc., November 10, 2025) says: “SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tiotropium have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tiotropium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tiotropium been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tiotropium?
- 3 companies list prescription products of Tiotropium in the FDA NDC Directory, including Boehringer Ingelheim Pharmaceuticals, Inc., A-S Medication Solutions and Lupin Pharmaceuticals, Inc..
What Tiotropium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. …
— FDA label: Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Spray, metered |
|---|---|
| Route | Respiratory (inhalation) · Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Spiriva Handihaler, Spiriva Respimat |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tiotropium bromide anhydrous 1.562 ug spray, metered | Brand: Spiriva Respimat | $126.02 per gram |
| tiotropium bromide anhydrous 3.124 ug spray, metered | Brand: Spiriva Respimat | $126.09 per gram |
| tiotropium bromide monohydrate 18 ug capsule | Generic | $11.90 per capsule |
| tiotropium bromide monohydrate 18 ug capsule | Brand: Spiriva HandiHaler | $10.60–$11.62 per capsule 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Boehringer Ingelheim Pharmaceuticals, Inc.3 products
- A-S Medication Solutions2 products
- Lupin Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021395 SPIRIVA | Boehringer Ingelheim | January 30, 2004 | 19, latest December 30, 2024 2024: Labeling · 2018: Labeling · 2016: Labeling |
| NDA021936 SPIRIVA RESPIMAT | Boehringer Ingelheim | September 24, 2014 | 5, latest December 27, 2024 2024: Labeling · 2019: Labeling · 2017: Efficacy |
| NDA207070 SPIRIVA RESPIMAT | Boehringer Ingelheim | September 15, 2015 | — |
Generic approvals (1)
- ANDA211287Lupin · June 20, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 26, 2022 · Class II · Terminated · D-0197-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceutic — CARDINAL HEALTHCARE
-
March 15, 2021 · Class II · Terminated · D-0453-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Ge — Cardinal Health Inc.
-
December 14, 2017 · Class II · Terminated · D-0242-2018
Failed Stability Specifications
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, C — Boehringer Ingelheim Pharmaceuticals, Inc.
-
March 27, 2014 · Class III · Terminated · D-1230-2014
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister c — Boehringer Ingelheim Roxane Inc
-
August 30, 2013 · Class III · Terminated · D-1057-2013
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 co — Boehringer Ingelheim Roxane Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →