NDC 16590-211
Sulindac 200 mg tablet
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Epic Pharma, LLC's NDC 42806-011.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Epic Pharma, LLC | Laurelton, NY, United States | Makes it | Problems found, fixed voluntarilyJun 12, 2026 · 14 inspections |
Repackaging site
- Stat Rx USA, Location not on file · repackages it and relabels it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 1578F201
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sulindac: every company that makes it
- Form
- tablet
- Strength
- 200 mg
- Approval
- ANDA ANDA072711
- On the market since
- Jan 25, 2010
- Package NDCs
16590-211-3016590-211-60- Official label
- DailyMed (National Library of Medicine), updated Aug 17, 2012
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?