NDC 67046-1209
Tramadol Hydrochloride 50 mg tablet, coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Amneal Pharmaceuticals's NDC 60219-2348.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 24, 2025 · 9 inspections |
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | No problems foundJul 19, 2024 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Mar 19, 2026 · Class II · Amneal Pharmaceuticals, LLC
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Lots: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tramadol: every company that makes it
- Form
- tablet, coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA076003
- On the market since
- Jun 22, 2026
- Package NDCs
67046-1209-3- Official label
- DailyMed (National Library of Medicine), updated Jun 22, 2026
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