Home NDC 71335-9679 Zonisamide
Product NDC 71335-9679
11-digit product format 713359679
Labeler code 71335
Product ID 71335-9679_22af5ef5-8818-47b2-b0fa-f1401aa89e75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA214492
Marketing category ANDA
Marketing start 2021-07-09
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 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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9679 ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK] 100 Current NDC, 5 package rows 20230407_2d569c8a-844b-44a8-81df-3f9c9300a79c.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 Sample Exclude flag Status 71335-9679-1 71335967901 100 CAPSULE in 1 BOTTLE (71335-9679-1) 100 capsule 2023-04-06 No No Current 71335-9679-2 71335967902 90 CAPSULE in 1 BOTTLE (71335-9679-2) 90 capsule 2023-04-06 No No Current 71335-9679-3 71335967903 30 CAPSULE in 1 BOTTLE (71335-9679-3) 30 capsule 2023-04-06 No No Current 71335-9679-4 71335967904 60 CAPSULE in 1 BOTTLE (71335-9679-4) 60 capsule 2023-04-06 No No Current 71335-9679-5 71335967905 120 CAPSULE in 1 BOTTLE (71335-9679-5) 120 capsule 2023-04-06 No No Current