Zonisamide Capsules

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-10-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-10-10 01:05:39

Label at a glance#

ProductZonisamide
Active ingredientZONISAMIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1142-1 in bottle of 100 Capsules

Zonisamide Capsules, 25 mg

Rx only

100 Capsules

Zonisamide Capsules, 25 mg
Zonisamide Capsules, 25 mg

NDC 70771-1143-1 in bottle of 100 Capsules

Zonisamide Capsules, 50 mg

Rx only

100 Capsules

Zonisamide Capsules, 50 mg
Zonisamide Capsules, 50 mg

NDC 70771-1144-1 in bottle of 100 Capsules

Zonisamide Capsules, 100 mg

Rx only

100 Capsules

Zonisamide Capsules, 100 mg
Zonisamide Capsules, 100 mg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372578042011GTIN-13: 0372578042011
EAN-13: 0372578042011
GTIN-12: 372578042011
UPC-A: 372578042011
GTIN storage (14 digits): 00372578042011
1442d938-61eb-438e-b5be-900bda532050-03.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ca446c7-87bf-4d4c-9a5f-4c587ab0290fProduct name120230316
c27132c2-a1b9-fc49-b84e-22e55312d19eProduct name220210621

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-08-16full-release2026-05-31 21:10:56

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077625-001ZONISAMIDEZONISAMIDE25MGCAPSULE / ORALAB2006-10-16
A077625-002ZONISAMIDEZONISAMIDE50MGCAPSULE / ORALAB2006-10-16
A077625-003ZONISAMIDEZONISAMIDE100MGCAPSULE / ORALAB2006-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077625-001AB
A077625-002AB
A077625-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-1684e616aacf4f…
2026-09-14 22:38:342026-08A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-1684e616aacf4f…
2026-09-14 22:38:342026-08A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-1684e616aacf4f…
2026-08-18 06:07:402026-07A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-002ZONISAMIDE50MGCAPSULE / ORALAB2006-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-003ZONISAMIDE100MGCAPSULE / ORALAB2006-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077625-001ZONISAMIDE25MGCAPSULE / ORALAB2006-10-16301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077625-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077625-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077625-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077625-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077625-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077625-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077625-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077625-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077625-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077625-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077625-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077625-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077625-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077625-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077625-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077625-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077625-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077625-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077625-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077625-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077625-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077625-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077625-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077625-001AB1301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e34d1910-1076-499e-8f3e-1cb18e2a39eb4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f2024-08-16Exact identifier
spl set id: 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.