NDC 47335-633
Budesonide 1 mg per 2 mL suspension
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited) | Halol Panchmahal, India | Makes it and tests it | No problems foundFeb 27, 2024 · 4 inspections |
Recalls
- May 29, 2026 · Class II · Sun Pharmaceutical Industries Inc
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Lots: Lot #: BAG0074A, Exp. Date: 1/31/2027.
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
- suspension, respiratory (inhalation)
- Strength
- 1 mg per 2 mL
- Approval
- ANDA ANDA211922
- On the market since
- May 1, 2021
- Package NDCs
47335-633-4847335-633-49- Official label
- DailyMed (National Library of Medicine), updated Apr 14, 2026
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