Zonisamide

Product NDC: 68788-7438
11-digit product format: 687887438
Labeler code: 68788
Product ID: 68788-7438_f89c358d-7cac-47a8-896e-5580c38b102e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA077634
Marketing category: ANDA
Marketing start: 2006-03-17
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	Approval date
A077634-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	2006-03-17
A077634-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	2006-03-17
A077634-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	2006-03-17

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	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077634-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077634-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077634-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077634-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077634-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077634-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077634-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077634-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077634-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077634-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077634-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077634-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077634-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077634-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077634-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077634-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077634-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077634-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077634-001	AB	1	`4b0b4de00fa7…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314285	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
53ecba6c-0de4-4e11-81d5-6deac79accd5	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	SPL version
68788-7438-1	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	7
68788-7438-3	Zonisamide	30 in 1 BOTTLE	CAPSULE	30	7
68788-7438-6	Zonisamide	60 in 1 BOTTLE	CAPSULE	60	7
68788-7438-9	Zonisamide	90 in 1 BOTTLE	CAPSULE	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7438-1	EA - Each	68788-7438	9e84fe21-bf4f-47ca-803d-7b782dcc005e	1	2020-04-20
68788-7438-3	EA - Each	68788-7438	20f50301-ca63-4b67-9b8d-8a0c0baa3893	1	2020-04-20
68788-7438-6	EA - Each	68788-7438	60eaeed7-55e2-450a-8c69-9870c31614b4	1	2020-04-20
68788-7438-9	EA - Each	68788-7438	b7ef8090-9914-4eaf-af36-45626df60fda	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7438	ZONISAMIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240907_53ecba6c-0de4-4e11-81d5-6deac79accd5.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	467a73f0-1cd1-46bf-83b3-ee38badb761c	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634
Zonisamide	ZONISAMIDE	Sun Pharmaceutical Industries, Inc.	3164d438-90bf-420a-9a56-5498b987f91c	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals, Inc.	53ecba6c-0de4-4e11-81d5-6deac79accd5	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634 ndc (product): 68788-7438
Zonisamide	ZONISAMIDE	Direct_Rx	e64b78d8-79de-337b-e053-2a95a90a4861	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634
Zonisamide	ZONISAMIDE	Proficient Rx LP	812582ce-fc7e-44b1-a428-7faa3701c1b8	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077634 application number: ANDA077634

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	53ecba6c-0de4-4e11-81d5-6deac79accd5	7
314285	zonisamide 100 MG Oral Capsule	SCD	53ecba6c-0de4-4e11-81d5-6deac79accd5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7438-1	68788743801	100 CAPSULE in 1 BOTTLE (68788-7438-1)	100 capsule	2019-12-26	0000-00-00	No	No	Current
68788-7438-3	68788743803	30 CAPSULE in 1 BOTTLE (68788-7438-3)	30 capsule	2019-12-26	0000-00-00	No	No	Current
68788-7438-6	68788743806	60 CAPSULE in 1 BOTTLE (68788-7438-6)	60 capsule	2019-12-26	0000-00-00	No	No	Current
68788-7438-9	68788743809	90 CAPSULE in 1 BOTTLE (68788-7438-9)	90 capsule	2019-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, for oral administration Rx only	Preferred Pharmaceuticals, Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	7