NDC 61919-591

Zonisamide 50 mg capsule

On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-129.

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

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.

Generic drug: Zonisamide: every company that makes it
Form: capsule
Strength: 50 mg
Approval: ANDA ANDA077651
On the market since: Jan 1, 2015
Package NDCs: 61919-591-60
Official label: DailyMed (National Library of Medicine), updated Sep 2, 2015

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