Home NDC 29300-429 Zonisamide
Product NDC 29300-429
11-digit product format 293000429
Labeler code 29300
Product ID 29300-429_337bce43-76dd-4e1c-bd1d-fcfc078baf0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA214492
Marketing category ANDA
Marketing start 2021-07-09
Substance ZONISAMIDE
Active strength 50 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 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 A214492-001 ZONISAMIDE ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 A214492-002 ZONISAMIDE ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 A214492-003 ZONISAMIDE ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26
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 3 · 105 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 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214492-002 ZONISAMIDE 50MG CAPSULE / ORAL AB 2021-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214492-003 ZONISAMIDE 100MG CAPSULE / ORAL AB 2021-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214492-001 ZONISAMIDE 25MG CAPSULE / ORAL AB 2021-01-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zonisamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZONISAMIDE 50 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 29300-429-01 Zonisamide 100 in 1 BOTTLE CAPSULE 100 5 29300-429-05 Zonisamide 500 in 1 BOTTLE CAPSULE 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-429 ZONISAMIDE CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] 5 Current NDC, Legacy NDC, 2 package rows 20221201_3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0.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 · 4 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 29300-429-01 29300042901 100 CAPSULE in 1 BOTTLE (29300-429-01) 100 capsule 2021-07-09 0000-00-00 No No Current 29300-429-05 29300042905 500 CAPSULE in 1 BOTTLE (29300-429-05) 500 capsule 2021-07-09 0000-00-00 No No Current