Zonisamide

Product NDC
62756-260
11-digit product format
627560260
Labeler code
62756
Product ID
62756-260_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
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
62756-260-01Zonisamide30 in 1 BOTTLECAPSULE3010
62756-260-02Zonisamide100 in 1 BOTTLECAPSULE10010
62756-260-03Zonisamide100 in 1 BOTTLECAPSULE10010
62756-260-04Zonisamide1000 in 1 BOTTLECAPSULE100010
62756-260-05Zonisamide500 in 1 BOTTLECAPSULE50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-260ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 5 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
314285zonisamide 100 MG Oral CapsulePSN53ecba6c-0de4-4e11-81d5-6deac79accd57
314285zonisamide 100 MG Oral CapsuleSCD53ecba6c-0de4-4e11-81d5-6deac79accd57
314285zonisamide 100 MG Oral CapsulePSN907c965e-8faf-53db-e053-2995a90a8cd15
314285zonisamide 100 MG Oral CapsulePSN812582ce-fc7e-44b1-a428-7faa3701c1b85
314285zonisamide 100 MG Oral CapsulePSN6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d5
314285zonisamide 100 MG Oral CapsuleSCD6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d5
314285zonisamide 100 MG Oral CapsuleSCD907c965e-8faf-53db-e053-2995a90a8cd15
314285zonisamide 100 MG Oral CapsuleSCD812582ce-fc7e-44b1-a428-7faa3701c1b85
314285zonisamide 100 MG Oral CapsulePSN31b97f07-9783-479d-b448-b272610a2f364
314285zonisamide 100 MG Oral CapsuleSCD31b97f07-9783-479d-b448-b272610a2f364
314285zonisamide 100 MG Oral CapsulePSN902a17d4-ce4f-476a-81d8-bb518041c8142
314285zonisamide 100 MG Oral CapsulePSNf89aba5c-bd19-4476-925c-bd7bd34723bb2
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
314285zonisamide 100 MG Oral CapsulePSN4696e856-69c4-4e7e-b76d-d70d85c4b5611
314285zonisamide 100 MG Oral CapsuleSCD4696e856-69c4-4e7e-b76d-d70d85c4b5611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-260-016275602600130 CAPSULE in 1 BOTTLE (62756-260-01) 30 capsule2006-03-170000-00-00NoNoCurrent
62756-260-0262756026002100 CAPSULE in 1 BOTTLE (62756-260-02) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-260-0362756026003100 CAPSULE in 1 BOTTLE (62756-260-03) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-260-04627560260041000 CAPSULE in 1 BOTTLE (62756-260-04) 1000 capsule2006-03-170000-00-00NoNoCurrent
62756-260-0562756026005500 CAPSULE in 1 BOTTLE (62756-260-05) 500 capsule2006-03-170000-00-00NoNoCurrent