Home DailyMed 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f Zonisamide Capsules Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
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# Product Zonisamide
Active ingredient ZONISAMIDE
Label structure 1 sections
Product Linked Resources# Resource, Code type, Value table Resource Code type Value Equivalent identifiers Source image Barcode EAN-13 0372578042011 GTIN-13: 0372578042011EAN-13: 0372578042011GTIN-12: 372578042011UPC-A: 372578042011GTIN storage (14 digits): 003725780420111442d938-61eb-438e-b5be-900bda532050-03.jpg
DailyMed Product Concepts# Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 8 matching rows.
Zonisamide FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 24 matching rows.
Older Hydrated Versions# Version, Effective date, Source table Version Effective date Source Hydrated 8 2024-08-16 full-release 2026-05-31 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077625-001 ZONISAMIDE ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 A077625-002 ZONISAMIDE ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 A077625-003 ZONISAMIDE ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.