NDC 58118-0460
Buprenorphine 8 mg tablet
On the label: Clinical Solutions Wholesale. It's repackaged: Clinical Solutions Wholesale rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 62756-460.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Repackaging site
- Clinical Solutions Wholesale, LLC, Franklin, TN, United States · repackages it
Recalls
- May 3, 2023 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations
Lots: Lot #: DND1515A, Exp 08/24
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Buprenorphine: every company that makes it
- Form
- tablet, sublingual
- Strength
- 8 mg
- Approval
- ANDA ANDA201760
- On the market since
- Feb 17, 2016
- Package NDCs
58118-0460-8- Official label
- DailyMed (National Library of Medicine), updated Feb 3, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?