Quick answers
- What is Spiriva HandiHaler?
- Spiriva HandiHaler is a brand name of Tiotropium, a prescription medicine. The FDA NDC Directory lists 3 Spiriva HandiHaler products in 1 strength and form.
- Who makes Spiriva HandiHaler?
- Boehringer Ingelheim holds the FDA application for Spiriva HandiHaler (NDA021395, approved January 30, 2004). 1 other company (repackagers or distributors) also list Spiriva HandiHaler products.
- Is there a generic or store brand of Spiriva HandiHaler?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Spiriva HandiHaler product, 1 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Spiriva HandiHaler?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Spiriva HandiHaler strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Spiriva HandiHaler been recalled?
- FDA enforcement reports list 5 recalls of Spiriva HandiHaler products; the newest started January 26, 2022. A recall usually concerns specific lots, not every product.
What Spiriva HandiHaler is
Each Spiriva HandiHaler product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Tiotropium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tiotropium bromide monohydrate 18 ug capsule (oral, respiratory (inhalation)) | Spiriva HandiHaler | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tiotropium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021395 | Boehringer Ingelheim | January 30, 2004 | 3 |
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 monohydrate 18 ug capsule | Brand: Spiriva HandiHaler | $10.60–$11.62 per capsule 3 packages, lowest to highest Generic of the same strength and form: $11.90 per capsule |
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 Spiriva HandiHaler
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Spiriva HandiHaler products.
- A-S Medication Solutions2 products
- Boehringer Ingelheim Pharmaceuticals, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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
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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.
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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
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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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.