Home NDC 59212-681 Zonegran
Product NDC 59212-681
11-digit product format 592120681
Labeler code 59212
Product ID 59212-681_66904ccc-bcd1-427c-95ed-bfa633bbf0b2
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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2000-03-27 N020789-002 ZONEGRAN ZONISAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 N020789-003 ZONEGRAN ZONISAMIDE 25MG CAPSULE / ORAL AB RLD 2003-08-22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 · 129 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 2026-09-14 22:38:34 2026-08 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020789-002 ZONEGRAN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020789-001 ZONEGRAN 100MG CAPSULE / ORAL AB RLD, RS 2000-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020789-003 ZONEGRAN 25MG CAPSULE / ORAL AB RLD 2003-08-22 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zonegran
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZONISAMIDE 25 mg/1
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
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