Zonisamide

Product NDC
62756-258
11-digit product format
627560258
Labeler code
62756
Product ID
62756-258_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
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62756-25862756-258-02DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077634-001ZONISAMIDEZONISAMIDE25MGCAPSULE / ORAL2006-03-17
A077634-002ZONISAMIDEZONISAMIDE50MGCAPSULE / ORAL2006-03-17
A077634-003ZONISAMIDEZONISAMIDE100MGCAPSULE / ORAL2006-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077634-001ZONISAMIDE25MGCAPSULE / ORAL2006-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077634-002ZONISAMIDE50MGCAPSULE / ORAL2006-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077634-003ZONISAMIDE100MGCAPSULE / ORAL2006-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077634-001ZONISAMIDE25MGCAPSULE / ORAL2006-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077634-002ZONISAMIDE50MGCAPSULE / ORAL2006-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077634-003ZONISAMIDE100MGCAPSULE / ORAL2006-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077634-001ZONISAMIDE25MGCAPSULE / ORAL2006-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077634-002ZONISAMIDE50MGCAPSULE / ORAL2006-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077634-003ZONISAMIDE100MGCAPSULE / ORAL2006-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-002ZONISAMIDE50MGCAPSULE / ORALAB2006-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-003ZONISAMIDE100MGCAPSULE / ORALAB2006-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077634-001ZONISAMIDE25MGCAPSULE / ORALAB2006-03-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077634-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077634-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077634-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077634-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077634-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077634-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077634-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077634-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077634-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077634-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077634-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077634-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077634-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077634-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077634-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077634-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077634-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077634-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077634-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077634-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077634-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077634-001AB14b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
Zonisamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
459384H98VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314285Internal RxNorm lookup
403966Internal RxNorm lookup
403967Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3164d438-90bf-420a-9a56-5498b987f91cAvailable on FDA.report

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
62756-258-01Zonisamide30 in 1 BOTTLECAPSULE3010
62756-258-02Zonisamide100 in 1 BOTTLECAPSULE10010
62756-258-03Zonisamide100 in 1 BOTTLECAPSULE10010
62756-258-04Zonisamide1000 in 1 BOTTLECAPSULE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-258-02EA - Each62756-25828d07746-0eda-4d57-b417-3ff7214b59de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-258ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 4 package rows20200818_3164d438-90bf-420a-9a56-5498b987f91c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZonisamideZONISAMIDEBryant Ranch Prepack467a73f0-1cd1-46bf-83b3-ee38badb761c2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
ZonisamideZONISAMIDEBryant Ranch Prepack6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
ZonisamideZONISAMIDESun Pharmaceutical Industries, Inc.3164d438-90bf-420a-9a56-5498b987f91c2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
ndc (product): 62756-258
ZonisamideZONISAMIDEPreferred Pharmaceuticals, Inc.53ecba6c-0de4-4e11-81d5-6deac79accd52025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
ZonisamideZONISAMIDEDirect_Rxe64b78d8-79de-337b-e053-2a95a90a48612025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
ZonisamideZONISAMIDEProficient Rx LP812582ce-fc7e-44b1-a428-7faa3701c1b82022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634

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
403966zonisamide 25 MG Oral CapsulePSNe64b78d8-79de-337b-e053-2a95a90a48612
403966zonisamide 25 MG Oral CapsuleSCDe64b78d8-79de-337b-e053-2a95a90a48612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-258-016275602580130 CAPSULE in 1 BOTTLE (62756-258-01) 30 capsule2006-03-170000-00-00NoNoCurrent
62756-258-0262756025802100 CAPSULE in 1 BOTTLE (62756-258-02) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-258-0362756025803100 CAPSULE in 1 BOTTLE (62756-258-03) 100 capsule2006-03-170000-00-00NoNoCurrent
62756-258-04627560258041000 CAPSULE in 1 BOTTLE (62756-258-04) 1000 capsule2006-03-170000-00-00NoNoCurrent