Home NDC 70518-3224-0 Zonisamide
Product NDC 70518-3224
Requested package NDC 70518-3224-0
11-digit product format 705183224
Labeler code 70518
Product ID 70518-3224_4ecfc1db-8d29-f850-e063-6394a90a2131
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077645
Marketing category ANDA
Marketing start 2021-09-16
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-3224 70518-3224-0 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 · 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 70518-3224-0 Zonisamide 100 in 1 BOX CAPSULE 100 7 70518-3224-1 Zonisamide 1 in 1 POUCH CAPSULE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3224 ZONISAMIDE CAPSULE [REMEDYREPACK INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240316_597f0a0b-e162-497c-9871-f2b73ebad245.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 70518-3224-0 70518322400 100 POUCH in 1 BOX (70518-3224-0) / 1 CAPSULE in 1 POUCH (70518-3224-1) 100 pouch 2021-09-16 0000-00-00 No No Current