NDC 67046-1361
Fenofibrate 145 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-596.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Sep 12, 2018 · Class III · Hetero Labs, Ltd. - Unit III
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Lots: Lot #: E181370, Exp. 5/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fenofibric Acid: every company that makes it
- Form
- tablet, film coated
- Strength
- 145 mg
- Approval
- ANDA ANDA204598
- On the market since
- Nov 12, 2024
- Package NDCs
67046-1361-3- Official label
- DailyMed (National Library of Medicine), updated Nov 12, 2024
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