NDC 67046-0582
Trazodone Hydrochloride 100 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-806.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Dec 19, 2025 · Class III · Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Lots: Lot # EA00237A, Exp Date: 04/30/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Trazodone: every company that makes it
- Form
- tablet
- Strength
- 100 mg
- Approval
- ANDA ANDA205253
- On the market since
- Dec 11, 2024
- Package NDCs
67046-0582-3- Official label
- DailyMed (National Library of Medicine), updated Dec 11, 2024
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