NDC 68084-343
Topiramate 50 mg tablet, film coated
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-139.
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
- American Health Packaging, Columbus, OH, 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. - Jul 25, 2012 · Class III · American Health Packaging
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Lots: Lot #: 113032A, 113032B, Exp 04/13
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
- 50 mg
- Approval
- ANDA ANDA078235
- On the market since
- Nov 8, 2019
- Package NDCs
68084-343-0168084-343-11- Official label
- DailyMed (National Library of Medicine), updated Sep 30, 2025
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