NDC 0597-0075 – Spiriva HandiHaler
Tiotropium Bromide Monohydrate 18 ug/1 · Capsule · Oral, Respiratory (inhalation)
Product NDC0597-0075
Product details
- Brand name
- Spiriva HandiHaler
- Generic name
- Tiotropium Bromide
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Capsule
- Route
- Oral, Respiratory (inhalation)
- Marketing category
- NDA · NDA021395
- Marketed since
- October 11, 2005
- Listing expires
- December 31, 2026
- Pharmacologic class
- Anticholinergic
Active ingredients
- Tiotropium Bromide Monohydrate 18 ug/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0075-41 | 3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK | Oct 11, 2005 |
| 0597-0075-47 | 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK | Oct 11, 2005 |
| 0597-0075-75 | 1 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACK | Oct 11, 2005 |
Recalls mentioning this NDC
- D-0197-2024 Jan 3, 2024 · Class II
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-0453-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0242-2018 Feb 7, 2018 · Class II
Failed Stability Specifications - D-1230-2014 Apr 16, 2014 · Class III
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. - D-1057-2013 Sep 25, 2013 · Class III
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
Other Spiriva products
- 50090-4248 Tiotropium Bromide Monohydrate 18 ug/1 · Capsule · A-S Medication Solutions
- 50090-7645 Tiotropium Bromide Monohydrate 18 ug/1 · Capsule · A-S Medication Solutions