NDC 61919-775
Zonisamide 100 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-130.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | Monroe, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyJun 17, 2025 · 2 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels it
Recalls
- May 13, 2022 · Class II · Direct Rx
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Lots: Lot: 23JY2124 Exp. 6/30/23 - Apr 25, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Lots: Lot #: 29200052, Exp 4/30/2023 - Apr 25, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Lots: Lot #: 29200064, Exp 5/31/2023 - Apr 25, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Lots: a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023 - Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022 - Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 2920…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Zonisamide: every company that makes it
- Form
- capsule
- Strength
- 100 mg
- Approval
- ANDA ANDA077651
- On the market since
- Aug 13, 2019
- Package NDCs
61919-775-3061919-775-90- Official label
- DailyMed (National Library of Medicine), updated Aug 23, 2021
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