Zonisamide

Product NDC: 68462-130
11-digit product format: 684620130
Labeler code: 68462
Product ID: 68462-130_c00ccc2d-52c6-4a11-a310-d8db25ca3928
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA077651
Marketing category: ANDA
Marketing start: 2006-01-30
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	Approval date
A077651-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30
A077651-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30
A077651-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077651-001	AB
A077651-002	AB
A077651-003	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314285	Internal RxNorm lookup
403966	Internal RxNorm lookup
403967	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe15e56e-8b86-4a65-825c-31d37dd81612	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ca446c7-87bf-4d4c-9a5f-4c587ab0290f	Product name	1	20230316
c27132c2-a1b9-fc49-b84e-22e55312d19e	Product name	2	20210621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-130-01	Zonisamide	100 in 1 BOTTLE	CAPSULE	100		14
68462-130-05	Zonisamide	500 in 1 BOTTLE	CAPSULE	500		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-130-01	EA - Each	68462-130	81137ead-69be-4031-b82c-6ca86c610e3a	1	2012-07-24
68462-130-05	EA - Each	68462-130	ac83f9a8-01bb-4242-ad6f-a8b059b122e0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
ZONISAMIDE	ACTIVE MOIETY	459384H98V	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-130	ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	13	Current NDC, Legacy NDC, 2 package rows	20220928_fe15e56e-8b86-4a65-825c-31d37dd81612.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	BluePoint Laboratories	345efcc4-6a36-4ddf-8b6c-9c6c844dab0a	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	1a859304-804a-4588-9961-c2e6ae09aadb	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Glenmark Pharmaceuticals Inc., USA	fe15e56e-8b86-4a65-825c-31d37dd81612	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651 ndc (product): 68462-130
Zonisamide	ZONISAMIDE	Proficient Rx LP	85321a9a-08d9-49e4-8c79-86ecfc536613	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
459384H98V	ZONISAMIDE	68291-97-4	ZONISAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314285	zonisamide 100 MG Oral Capsule	PSN	fe15e56e-8b86-4a65-825c-31d37dd81612	14
403966	zonisamide 25 MG Oral Capsule	PSN	fe15e56e-8b86-4a65-825c-31d37dd81612	14
403967	zonisamide 50 MG Oral Capsule	PSN	fe15e56e-8b86-4a65-825c-31d37dd81612	14
314285	zonisamide 100 MG Oral Capsule	SCD	fe15e56e-8b86-4a65-825c-31d37dd81612	14
403966	zonisamide 25 MG Oral Capsule	SCD	fe15e56e-8b86-4a65-825c-31d37dd81612	14
403967	zonisamide 50 MG Oral Capsule	SCD	fe15e56e-8b86-4a65-825c-31d37dd81612	14
314285	zonisamide 100 MG Oral Capsule	PSN	85321a9a-08d9-49e4-8c79-86ecfc536613	4
314285	zonisamide 100 MG Oral Capsule	SCD	85321a9a-08d9-49e4-8c79-86ecfc536613	4
314285	zonisamide 100 MG Oral Capsule	PSN	9001965b-dbf6-5504-e053-2a95a90a3c43	3
314285	zonisamide 100 MG Oral Capsule	SCD	9001965b-dbf6-5504-e053-2a95a90a3c43	3
314285	zonisamide 100 MG Oral Capsule	PSN	94c92836-8673-417a-b461-5b3e68c95b5e	2
314285	zonisamide 100 MG Oral Capsule	SCD	94c92836-8673-417a-b461-5b3e68c95b5e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-130-01	68462013001	100 CAPSULE in 1 BOTTLE (68462-130-01)	100 capsule	2006-01-30	0000-00-00	No	No	Current
68462-130-05	68462013005	500 CAPSULE in 1 BOTTLE (68462-130-05)	500 capsule	2006-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, USP for oral administration	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited \| Glenmark Pharmaceuticals Inc.	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	14
Zonisamide Capsules USP, for oral administration	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Zonisamide Capsules USP for oral administration	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	4
ZONISAMIDE	Direct_Rx	2021-08-23	HUMAN PRESCRIPTION DRUG LABEL	3
Zonisamide Capsules USP, for oral administration	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	2
Zonisamide Capsules USP, for oral administration	A-S Medication Solutions	2018-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
Zonisamide	Direct Rx	2016-06-22	HUMAN PRESCRIPTION DRUG LABEL	2