Zonisamide

Product NDC
76282-228
11-digit product format
762820228
Labeler code
76282
Product ID
76282-228_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
2006-07-05
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

Additional Listing Data#

Finished product
Yes
Brand name base
Zonisamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui314285, 403966, 403967

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ca446c7-87bf-4d4c-9a5f-4c587ab0290fProduct name120230316
c27132c2-a1b9-fc49-b84e-22e55312d19eProduct name220210621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-228-01Zonisamide100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-228-01EA - Each76282-228fdb7e213-503a-4bb8-8457-cce494e53e2a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-228ZONISAMIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20210828_24284954-0c29-458f-a9f8-97a7ad418ca7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN24284954-0c29-458f-a9f8-97a7ad418ca77
403966zonisamide 25 MG Oral CapsulePSN24284954-0c29-458f-a9f8-97a7ad418ca77
403967zonisamide 50 MG Oral CapsulePSN24284954-0c29-458f-a9f8-97a7ad418ca77
314285zonisamide 100 MG Oral CapsuleSCD24284954-0c29-458f-a9f8-97a7ad418ca77
403966zonisamide 25 MG Oral CapsuleSCD24284954-0c29-458f-a9f8-97a7ad418ca77
403967zonisamide 50 MG Oral CapsuleSCD24284954-0c29-458f-a9f8-97a7ad418ca77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-228-0176282022801100 CAPSULE in 1 BOTTLE (76282-228-01) 100 capsule2006-07-050000-00-00NoNoCurrent