Home NDC 0378-6727 Zonisamide
Product NDC 0378-6727
11-digit product format 003786727
Labeler code 0378
Product ID 0378-6727_2cf3045b-a102-4257-8f94-0971aa729d12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zonisamide
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA077637
Marketing category ANDA
Marketing start 2005-12-23
Marketing end 2019-12-31
Substance ZONISAMIDE
Active strength 100 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077637-001 ZONISAMIDE ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 A077637-002 ZONISAMIDE ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 A077637-003 ZONISAMIDE ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22
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 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077637-002 ZONISAMIDE 50MG CAPSULE / ORAL 2005-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077637-003 ZONISAMIDE 100MG CAPSULE / ORAL 2005-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077637-001 ZONISAMIDE 25MG CAPSULE / ORAL 2005-12-22 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZONISAMIDE ACTIVE INGREDIENT 459384H98V ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 ZONISAMIDE ACTIVE MOIETY 459384H98V ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SHELLAC INACTIVE INGREDIENT 46N107B71O ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 ZONISAMIDE ACTIVE INGREDIENT 459384H98V ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 ZONISAMIDE ACTIVE MOIETY 459384H98V ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 7