NDC 67046-1540
Trazodone Hydrochloride 100 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Granules Pharmaceuticals Inc.'s NDC 70010-232.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granules India Limited | Medchal-Malkajgiri District, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 14, 2020 · 6 inspections |
| Granules Pharmaceuticals Inc. | Chantilly, VA, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 3, 2026 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Jan 26, 2026 · Class II · Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules
Lots: Batch # 6160008A, Exp Date: 12/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Trazodone: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA218988
- On the market since
- Mar 25, 2025
- Package NDCs
67046-1540-3- Official label
- DailyMed (National Library of Medicine), updated Mar 25, 2025
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