NDC 80425-0398
topiramate 100 mg tablet, film coated
On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-140.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Repackaging site
- Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, United States · repackages it
Recalls
- Sep 15, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Lots: Lot #: MN9828, Expiry: Oct 2015.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Topiramate: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA078235
- On the market since
- Jun 4, 2024
- Package NDCs
80425-0398-180425-0398-280425-0398-3- Official label
- DailyMed (National Library of Medicine), updated Jun 4, 2024
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