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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-6727DDiscontinued by firm2026-08-03
excluded packagepackage0378-67270378-6727-01DDiscontinued by firm2026-08-03
excluded packagepackage0378-67270378-6727-05DDiscontinued by firm2026-08-03

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-6727-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-6727-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-6727-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-6727-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-6727-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-6727-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-6727-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-6727-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-6727-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-6727-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-6727-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-6727-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-6727-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-6727-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-6727-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-6727-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-6727-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-6727-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-6727-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-6727-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-6727-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-6727-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-6727-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-6727-05557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077637-001ZONISAMIDEZONISAMIDE25MGCAPSULE / ORAL2005-12-22
A077637-002ZONISAMIDEZONISAMIDE50MGCAPSULE / ORAL2005-12-22
A077637-003ZONISAMIDEZONISAMIDE100MGCAPSULE / ORAL2005-12-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077637-002ZONISAMIDE50MGCAPSULE / ORAL2005-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077637-003ZONISAMIDE100MGCAPSULE / ORAL2005-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077637-001ZONISAMIDE25MGCAPSULE / ORAL2005-12-228072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077637-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077637-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077637-003AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A077637-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077637-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077637-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077637-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077637-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077637-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6727-01EA - Each0378-6727c4234e51-9493-45cd-b0ae-74499d74b51812012-07-24
0378-6727-05EA - Each0378-672741b5c72b-ed9e-4b1d-b295-07b17e57d5df12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]11
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]7