NDC 69097-173
Ipratropium Bromide and Albuterol Sulfate 0.5 mg per 3 mL / 2.5 mg per 3 mL solution
On the label: Cipla USA., Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Salcette, India | Makes it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
| Cipla Limited | Indore, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 17, 2023 · 6 inspections, 1 with FDA action |
Recalls
- Mar 26, 2024 · Class II · Cipla USA, Inc.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Lots: Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Albuterol and Ipratropium: every company that makes it
- Form
- solution, respiratory (inhalation)
- Strength
- 0.5 mg per 3 mL / 2.5 mg per 3 mL
- Approval
- ANDA ANDA077559
- On the market since
- Dec 31, 2007
- Package NDCs
69097-173-5369097-173-64- Official label
- DailyMed (National Library of Medicine), updated Jun 22, 2026
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