NDC 76420-558
Spironolactone 100 mg tablet, film coated
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 53489-329.
Where the pills inside were 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 |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
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
- 100 mg
- Approval
- ANDA ANDA089424
- On the market since
- Jul 23, 1986
- Package NDCs
76420-558-0176420-558-3076420-558-6076420-558-90- Official label
- DailyMed (National Library of Medicine), updated Apr 7, 2023
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