NDC 53489-328
Spironolactone 50 mg tablet, film coated
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Frontida BioPharm, LLC | Philadelphia, PA, United States | Makes it | No problems foundApr 2, 2026 · 10 inspections, 1 with FDA action |
Recalls
- Aug 5, 2025 · Class II · Sun Pharmaceutical Industries Inc
Presence of foreign substance: identified as aluminum.
Lots: Lot # P3314, Exp 11/30/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Spironolactone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA089424
- On the market since
- Jul 23, 1986
- Package NDCs
53489-328-0153489-328-0253489-328-0353489-328-0553489-328-0653489-328-0753489-328-10- Official label
- DailyMed (National Library of Medicine), updated Jul 31, 2026
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