NDC 63629-1067
Spironolactone 50 mg tablet, film coated
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 53489-328.
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
- Bryant Ranch Prepack, Burbank, 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 - Jan 27, 2021 · Class II · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Lots: Lot #: 148992, Exp 5/31/2022
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
63629-1067-163629-1067-263629-1067-363629-1067-4- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2026
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