Zonisamide

Product NDC
68788-7438
11-digit product format
687887438
Labeler code
68788
Product ID
68788-7438_f89c358d-7cac-47a8-896e-5580c38b102e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077634
Marketing category
ANDA
Marketing start
2006-03-17
Substance
ZONISAMIDE
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
459384H98VZONISAMIDE68291-97-4ZONISAMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-7438-168788743801100 CAPSULE in 1 BOTTLE (68788-7438-1) 100 capsule2019-12-26NoNoHistorical
68788-7438-36878874380330 CAPSULE in 1 BOTTLE (68788-7438-3) 30 capsule2019-12-26NoNoHistorical
68788-7438-66878874380660 CAPSULE in 1 BOTTLE (68788-7438-6) 60 capsule2019-12-26NoNoHistorical
68788-7438-96878874380990 CAPSULE in 1 BOTTLE (68788-7438-9) 90 capsule2019-12-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zonisamide Capsules, for oral administration Rx onlyPreferred Pharmaceuticals, Inc.2025-10-08HUMAN PRESCRIPTION DRUG LABEL7
Zonisamide Capsules, for oral administration Rx onlyPreferred Pharmaceuticals, Inc.2024-09-06HUMAN PRESCRIPTION DRUG LABEL6