NDC 72189-311
Tramadol Hydrochloride 50 mg tablet, coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Advagen Pharma Ltd.'s NDC 72888-080.
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
- Direct Rx, Dawsonville, GA, 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
- 50 mg
- Approval
- ANDA ANDA208708
- On the market since
- Jan 12, 2022
- Package NDCs
72189-311-1272189-311-2072189-311-3072189-311-4072189-311-6072189-311-7272189-311-8272189-311-8472189-311-90- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?