Home NDC 80425-0392 Zonisamide
Product NDC 80425-0392
11-digit product format 804250392
Labeler code 80425
Product ID 80425-0392_19b070b3-73b3-4f4a-e063-6294a90af594
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA077625
Marketing category ANDA
Marketing start 2024-05-23
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A077625-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077625-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077625-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2006-10-16 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zonisamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZONISAMIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 459384H98V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314285 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0392-1 Zonisamide 30 in 1 BOTTLE CAPSULE 30 1 80425-0392-2 Zonisamide 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0392 ZONISAMIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 1 Current NDC, 2 package rows 20240601_19b059f0-a08a-f75a-e063-6294a90a57db.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0392-1 80425039201 30 CAPSULE in 1 BOTTLE (80425-0392-1) 30 capsule 2024-05-23 No No Current 80425-0392-2 80425039202 60 CAPSULE in 1 BOTTLE (80425-0392-2) 60 capsule 2024-05-23 No No Current