Zonisamide

Product NDC
62756-259
11-digit product format
627560259
Labeler code
62756
Product ID
62756-259_d0c9002b-fa32-4ca8-862f-5286746df2cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077634
Marketing category
ANDA
Marketing start
2006-03-17
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE50 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
62756-259-01Zonisamide30 in 1 BOTTLECAPSULE3010
62756-259-02Zonisamide100 in 1 BOTTLECAPSULE10010
62756-259-03Zonisamide100 in 1 BOTTLECAPSULE10010
62756-259-04Zonisamide1000 in 1 BOTTLECAPSULE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-259ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 4 package rows20200818_3164d438-90bf-420a-9a56-5498b987f91c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN3164d438-90bf-420a-9a56-5498b987f91c10
403966zonisamide 25 MG Oral CapsulePSN3164d438-90bf-420a-9a56-5498b987f91c10
403967zonisamide 50 MG Oral CapsulePSN3164d438-90bf-420a-9a56-5498b987f91c10
314285zonisamide 100 MG Oral CapsuleSCD3164d438-90bf-420a-9a56-5498b987f91c10
403966zonisamide 25 MG Oral CapsuleSCD3164d438-90bf-420a-9a56-5498b987f91c10
403967zonisamide 50 MG Oral CapsuleSCD3164d438-90bf-420a-9a56-5498b987f91c10
403967zonisamide 50 MG Oral CapsulePSN467a73f0-1cd1-46bf-83b3-ee38badb761c5
403967zonisamide 50 MG Oral CapsuleSCD467a73f0-1cd1-46bf-83b3-ee38badb761c5
314285zonisamide 100 MG Oral CapsulePSNf89aba5c-bd19-4476-925c-bd7bd34723bb2
314285zonisamide 100 MG Oral CapsulePSN902a17d4-ce4f-476a-81d8-bb518041c8142
403967zonisamide 50 MG Oral CapsulePSN902a17d4-ce4f-476a-81d8-bb518041c8142
403967zonisamide 50 MG Oral CapsulePSNf89aba5c-bd19-4476-925c-bd7bd34723bb2
314285zonisamide 100 MG Oral CapsuleSCD902a17d4-ce4f-476a-81d8-bb518041c8142
314285zonisamide 100 MG Oral CapsuleSCDf89aba5c-bd19-4476-925c-bd7bd34723bb2
403967zonisamide 50 MG Oral CapsuleSCD902a17d4-ce4f-476a-81d8-bb518041c8142
403967zonisamide 50 MG Oral CapsuleSCDf89aba5c-bd19-4476-925c-bd7bd34723bb2
403967zonisamide 50 MG Oral CapsulePSN062ea00d-ba12-4667-a6e3-7d7a6d82bb7b1
403967zonisamide 50 MG Oral CapsuleSCD062ea00d-ba12-4667-a6e3-7d7a6d82bb7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-259-016275602590130 CAPSULE in 1 BOTTLE (62756-259-01) 30 capsule2006-03-170000-00-00NoNoCurrent
62756-259-0262756025902100 CAPSULE in 1 BOTTLE (62756-259-02) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-259-0362756025903100 CAPSULE in 1 BOTTLE (62756-259-03) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-259-04627560259041000 CAPSULE in 1 BOTTLE (62756-259-04) 1000 capsule2006-03-170000-00-00NoNoCurrent