NDC 69097-840
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 |
|---|---|---|---|
| The Ritedose Corporation | Columbia, SC, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 28, 2025 · 12 inspections |
Recalls
- Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots: Batch 21C56
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 ANDA202496
- On the market since
- Jun 1, 2020
- Package NDCs
69097-840-3469097-840-5369097-840-6469097-840-87- Official label
- DailyMed (National Library of Medicine), updated Jan 11, 2024
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