FDA.reportPublic FDA data

Zonisamide

Product NDC
68462-128
11-digit product format
684620128
Labeler code
68462
Product ID
68462-128_c00ccc2d-52c6-4a11-a310-d8db25ca3928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077651
Marketing category
ANDA
Marketing start
2006-01-30
Substance
ZONISAMIDE
Active strength
25 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
ZONISAMIDE25 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
68462-128-01Zonisamide100 in 1 BOTTLECAPSULE10014
68462-128-05Zonisamide500 in 1 BOTTLECAPSULE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-128-01EA - Each68462-128eb5f7183-2d04-4981-b443-b76927af135212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-128ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 2 package rows20220928_fe15e56e-8b86-4a65-825c-31d37dd81612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSNfe15e56e-8b86-4a65-825c-31d37dd8161214
403966zonisamide 25 MG Oral CapsulePSNfe15e56e-8b86-4a65-825c-31d37dd8161214
403967zonisamide 50 MG Oral CapsulePSNfe15e56e-8b86-4a65-825c-31d37dd8161214
314285zonisamide 100 MG Oral CapsuleSCDfe15e56e-8b86-4a65-825c-31d37dd8161214
403966zonisamide 25 MG Oral CapsuleSCDfe15e56e-8b86-4a65-825c-31d37dd8161214
403967zonisamide 50 MG Oral CapsuleSCDfe15e56e-8b86-4a65-825c-31d37dd8161214
403966zonisamide 25 MG Oral CapsulePSN1a859304-804a-4588-9961-c2e6ae09aadb2
403966zonisamide 25 MG Oral CapsulePSN50bb1a0a-a66d-4a13-a456-a10c1b8c8e942
403966zonisamide 25 MG Oral CapsuleSCD1a859304-804a-4588-9961-c2e6ae09aadb2
403966zonisamide 25 MG Oral CapsuleSCD50bb1a0a-a66d-4a13-a456-a10c1b8c8e942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-128-0168462012801100 CAPSULE in 1 BOTTLE (68462-128-01) 100 capsule2006-01-300000-00-00NoNoCurrent
68462-128-0568462012805500 CAPSULE in 1 BOTTLE (68462-128-05) 500 capsule2006-01-300000-00-00NoNoCurrent