Home NDC 59212-681 Zonegran
Product NDC 59212-681
11-digit product format 592120681
Labeler code 59212
Product ID 59212-681_e3848741-066e-4ee2-bf13-0b4c1d32b3c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Advanz Pharma (US) Corp.
Application NDA020789
Marketing category NDA
Marketing start 2000-03-27
Substance ZONISAMIDE
Active strength 25 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 N020789-001 ZONEGRAN ZONISAMIDE 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 N020789-002 ZONEGRAN ZONISAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 N020789-003 ZONEGRAN ZONISAMIDE 25MG CAPSULE / ORAL AB RLD 2003-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zonegran
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZONISAMIDE 25 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284408 Internal RxNorm lookup 314285 Internal RxNorm lookup 403966 Internal RxNorm lookup 404725 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 59212-681-10 Zonegran 100 in 1 BOTTLE CAPSULE 100 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59212-681 ZONEGRAN (ZONISAMIDE) CAPSULE [ADVANZ PHARMA (US) CORP.] 11 Current NDC, Legacy NDC, 1 package rows 20241224_d12de43e-3ac3-4335-bc85-70d7366a91eb.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 · 1 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 59212-681-10 59212068110 100 CAPSULE in 1 BOTTLE (59212-681-10) 100 capsule 2000-03-27 0000-00-00 No No Current