PillTiotropium Bromide
Brands: Spiriva Handihaler · Tiotropium Bromide Monohydrate
3 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 4 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it3 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | unknown | 3 | SUPPLYING |
| A-S Medication Solutions | unknown | 2 | SUPPLYING |
| Lupin Pharmaceuticals,Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 26, 2022RECALLRecall (Class II): SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card conta…
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — Recalling firm: CARDINAL HEALTHCARE — Nationwide USA
- Mar 15, 2021RECALLRecall (Class II): Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule R…
CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Recalling firm: Cardinal Health Inc. — FL, GA, SC
- Dec 14, 2017RECALLRecall (Class II): SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx…
Failed Stability Specifications — Recalling firm: Boehringer Ingelheim Pharmaceuticals, Inc. — Distributed nationwide
- Mar 27, 2014RECALLRecall (Class III): Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Onl…
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. — Recalling firm: Boehringer Ingelheim Roxane Inc — Nationwide and Puerto Rico
- Aug 30, 2013RECALLRecall (Class III): SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0…
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 — Recalling firm: Boehringer Ingelheim Roxane Inc — Nationwide