NDC 67046-1541
Tramadol Hydrochloride 100 mg tablet, coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Advagen Pharma Ltd.'s NDC 72888-008.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Rubicon Research Limited | Thane, India | Makes it and tests it | No problems foundMar 8, 2024 · 5 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Apr 26, 2024 · Class II · Rubicon Research Private Limited
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Lots: Lot #: 230774Hl, Exp 4/30/2026
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
- 100 mg
- Approval
- ANDA ANDA208708
- On the market since
- Mar 25, 2025
- Package NDCs
67046-1541-3- Official label
- DailyMed (National Library of Medicine), updated Mar 25, 2025
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