NDC 68071-3761
Febuxostat 80 mg tablet, film coated
On the label: NuCare Pharmaceuticals.Inc.. It's repackaged: NuCare Pharmaceuticals.Inc. rebottles it from Northstar Rx LLC.'s NDC 16714-060.
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
- NuCare Pharmaceuticals,Inc., Orange, CA, United States · repackages it
Recalls
- Mar 4, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025 - Mar 4, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #: DNE0894A, Exp 07/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Febuxostat: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 80 mg
- Approval
- ANDA ANDA205467
- On the market since
- Jan 26, 2021
- Package NDCs
68071-3761-9- Official label
- DailyMed (National Library of Medicine), updated Jan 10, 2025
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