Zonisamide

Product NDC
76282-227
11-digit product format
762820227
Labeler code
76282
Product ID
76282-227_5b700833-52ca-46ef-8874-67b56595db24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA077869
Marketing category
ANDA
Marketing start
2021-03-15
Substance
ZONISAMIDE
Active strength
50 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
76282-227-0176282022701100 CAPSULE in 1 BOTTLE (76282-227-01) 100 capsule2021-03-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zonisamide - Exelan Pharmaceuticals, Inc. | InvaGen Pharmaceuticals, Inc. | InvaGen Pharmaceuticals, IncExelan Pharmaceuticals, Inc. | InvaGen Pharmaceuticals, Inc. | InvaGen Pharmaceuticals, Inc2021-07-06Human Prescription Drug Label7