NDC 69097-319
BudesonideInhalation Suspension 0.5 mg per 2 mL inhalant
On the label: Cipla USA., Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla (Jiangsu) Pharmaceutical Co., Ltd. | Qidong, China | Makes it | Not inspected on record |
| Cipla Limited | Salcette, India | Makes it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
| Cipla Limited | Indore, India | Makes it | Serious problems, FDA actionFeb 17, 2023 · 6 inspections, 1 with FDA action |
Recalls
- Jun 30, 2025 · Class II · Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Lots: Batch # 4IA0505, Exp 09/31/2026 - Sep 15, 2022 · Class II · Cipla
Lack of Assurance of Sterility
Lots: Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Budesonide: every company that makes it
- Form
- inhalant, oral
- Strength
- 0.5 mg per 2 mL
- Approval
- ANDA ANDA205710
- On the market since
- Nov 16, 2017
- Package NDCs
69097-319-3269097-319-5369097-319-8669097-319-87- Official label
- DailyMed (National Library of Medicine), updated Jun 10, 2026
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