Home NDC 59651-380 Zonisamide
Product NDC 59651-380
11-digit product format 596510380
Labeler code 59651
Product ID 59651-380_b43ac632-68f3-43f6-aa79-41429a54e1ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077645
Marketing category ANDA
Marketing start 2020-08-17
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 2027-12-31
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 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 59651-380 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 59651-380 59651-380-82 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 59651-380-82 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 59651-380-82 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 59651-380-82 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 59651-380-82 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 59651-380-82 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 59651-380-82 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 59651-380-82 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 59651-380-82 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 59651-380-82 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 59651-380-82 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 59651-380-82 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 59651-380-82 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 59651-380-82 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 59651-380-82 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 59651-380-82 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 59651-380-82 6db9cb8d1e19…3449e1ec5b70…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077645-001 ZONISAMIDE ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 A077645-002 ZONISAMIDE ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 A077645-003 ZONISAMIDE ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077645-002 ZONISAMIDE 25MG CAPSULE / ORAL AB 2006-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077645-003 ZONISAMIDE 50MG CAPSULE / ORAL AB 2006-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077645-001 ZONISAMIDE 100MG CAPSULE / ORAL AB 2005-12-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zonisamide
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314285 Internal RxNorm lookup 403966 Internal RxNorm lookup 403967 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 59651-380-01 Zonisamide 100 in 1 BOTTLE CAPSULE 100 6 59651-380-03 Zonisamide 30 in 1 BOTTLE CAPSULE 30 6 59651-380-05 Zonisamide 500 in 1 BOTTLE CAPSULE 500 6 59651-380-60 Zonisamide 60 in 1 BOTTLE CAPSULE 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-380 ZONISAMIDE CAPSULE [AUROBINDO PHARMA LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20231007_ab0631ca-5339-4570-bc27-f1dd92de1d6f.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59651-380-01 59651038001 100 CAPSULE in 1 BOTTLE (59651-380-01) 100 capsule 2020-08-17 0000-00-00 No No Current 59651-380-03 59651038003 30 CAPSULE in 1 BOTTLE (59651-380-03) 30 capsule 2020-08-17 0000-00-00 No No Current 59651-380-05 59651038005 500 CAPSULE in 1 BOTTLE (59651-380-05) 500 capsule 2020-08-17 0000-00-00 No No Current 59651-380-60 59651038060 60 CAPSULE in 1 BOTTLE (59651-380-60) 60 capsule 2020-08-17 0000-00-00 No No Current 59651-380-82 59651038082 800 CAPSULE in 1 BAG (59651-380-82) 800 capsule 17-AUG-20 Current