NDC 45865-261
Tramadol Hydrochloride 50 mg tablet, coated
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals 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
- Rubicon Research Limited, Thane, India · makes it and tests it
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, 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
- Strength
- 50 mg
- Approval
- ANDA ANDA208708
- On the market since
- Feb 24, 2020
- Package NDCs
45865-261-3045865-261-60- Official label
- DailyMed (National Library of Medicine), updated May 7, 2024
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