NDC 47335-722
Febuxostat 80 mg tablet, film coated
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's 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 |
Recalls
- Jan 18, 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: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025 - Jan 18, 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: DNE0867A Exp. 06/30/2025, DNE0894B 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
- Jul 5, 2019
- Package NDCs
47335-722-1847335-722-8347335-722-88- Official label
- DailyMed (National Library of Medicine), updated Nov 6, 2023
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