NDC 43353-242
Zolpidem Tartrate 5 mg tablet
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Torrent Pharma, Inc.'s NDC 13668-007.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Piramal Pharma Limited | Pithampur, India | Makes it, tests it and packages it | No problems foundMay 19, 2023 · 8 inspections |
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it, makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, makes the active ingredient, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Zolpidem: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA077903
- On the market since
- Sep 5, 2007
- Package NDCs
43353-242-1043353-242-1443353-242-1543353-242-2043353-242-2843353-242-3043353-242-4543353-242-5343353-242-5943353-242-60- Official label
- DailyMed (National Library of Medicine), updated Dec 27, 2019
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