Zonisamide

Product NDC
63629-3293
Requested package NDC
63629-3293-2
11-digit product format
636293293
Labeler code
63629
Product ID
63629-3293_39303fe6-8d9f-4fa1-91fa-4b012e71d6cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077634-001ZONISAMIDE25MGCAPSULE / ORAL2006-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A077634-002ZONISAMIDE50MGCAPSULE / ORAL2006-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A077634-003ZONISAMIDE100MGCAPSULE / ORAL2006-03-17caaa826d4ba7…
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…

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
ZONISAMIDE100 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6690c2cf-1634-93c0-7b2e-0ad4ca70cd6dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3293-12022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-12022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-22022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-22022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-32022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-32022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-42022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-42022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-52022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-52022-01-04Zonisamide Capsules, for oral administration Rx only
63629-3293-12019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-12019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-22019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-22019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-32019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-32019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-42019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-42019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-52019-11-27Zonisamide Capsules, for oral administration Rx only
63629-3293-52019-11-27Zonisamide Capsules, for oral administration Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3293-1Zonisamide100 in 1 BOTTLECAPSULE1005
63629-3293-2Zonisamide90 in 1 BOTTLECAPSULE905
63629-3293-3Zonisamide30 in 1 BOTTLECAPSULE305
63629-3293-4Zonisamide60 in 1 BOTTLECAPSULE605
63629-3293-5Zonisamide120 in 1 BOTTLECAPSULE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3293-1EA - Each63629-3293345855df-bc82-4bd6-b5eb-138b5b97367512012-07-24
63629-3293-2EA - Each63629-3293ff623029-9fe3-48f9-8adc-aa154b801ddb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3293ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20231025_6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d.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
ndc (package): 63629-3293-2
ndc (product): 63629-3293
ndc11 (package): 63629329302
ZonisamideZONISAMIDESun Pharmaceutical Industries, Inc.3164d438-90bf-420a-9a56-5498b987f91c2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077634
application number: ANDA077634
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 CapsulePSN6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d5
314285zonisamide 100 MG Oral CapsuleSCD6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3293-26362932930290 CAPSULE in 1 BOTTLE (63629-3293-2) 90 capsule2008-11-180000-00-00NoNoCurrent