Zonisamide

Product NDC: 72578-042
Requested package NDC: 72578-042-01
11-digit product format: 725780042
Labeler code: 72578
Product ID: 72578-042_01fdcace-12a4-44bc-9962-ea4c79395f84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA077625
Marketing category: ANDA
Marketing start: 2022-07-04
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: 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	Approval date
A077625-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16
A077625-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16
A077625-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077625-001	AB
A077625-002	AB
A077625-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077625-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077625-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077625-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077625-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077625-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077625-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077625-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077625-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077625-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077625-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077625-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077625-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077625-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077625-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077625-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077625-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077625-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077625-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077625-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-001	AB	1	`301d65b070ca…`

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: Zonisamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZONISAMIDE	100 mg/1

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
72578-042-01	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	4
72578-042-05	Zonisamide	500 in 1 BOTTLE	CAPSULE	500	4
72578-042-10	Zonisamide	1000 in 1 BOTTLE	CAPSULE	1000	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-042-01	EA - Each	72578-042	48da8ee8-f3f1-4312-8d05-06ebcb0b13de	1	2022-10-06
72578-042-05	EA - Each	72578-042	33f8ca42-839b-476d-b301-9eef0cbeeed4	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-042	ZONISAMIDE CAPSULE [VIONA PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 3 package rows	20231121_5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	40094d96-e979-4b3e-840f-a96677480f96	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	33b84aaa-044d-4c15-bb21-d1ce8674eec9	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	5000f95c-c78d-4150-9a69-0ee2943cf2c3	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Preferred Pharmaceuticals Inc	061fdccc-d08e-4e42-8a32-54afb6c89701	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Direct_Rx	35bcaee1-001f-82da-e063-6394a90a4a0f	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Zydus Lifesciences Limited	4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f	2024-08-16		Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Advanced Rx Pharmacy of Tennessee, LLC	19b059f0-a08a-f75a-e063-6294a90a57db	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625
Zonisamide	ZONISAMIDE	Viona Pharmaceuticals Inc	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077625 application number: ANDA077625 ndc (package): 72578-042-01 ndc (product): 72578-042 ndc11 (package): 72578004201

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	40094d96-e979-4b3e-840f-a96677480f96	4
314285	zonisamide 100 MG Oral Capsule	PSN	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
403966	zonisamide 25 MG Oral Capsule	PSN	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
403967	zonisamide 50 MG Oral Capsule	PSN	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
314285	zonisamide 100 MG Oral Capsule	SCD	40094d96-e979-4b3e-840f-a96677480f96	4
314285	zonisamide 100 MG Oral Capsule	SCD	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
403966	zonisamide 25 MG Oral Capsule	SCD	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
403967	zonisamide 50 MG Oral Capsule	SCD	5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e	4
314285	zonisamide 100 MG Oral Capsule	PSN	061fdccc-d08e-4e42-8a32-54afb6c89701	1
314285	zonisamide 100 MG Oral Capsule	PSN	19b059f0-a08a-f75a-e063-6294a90a57db	1
314285	zonisamide 100 MG Oral Capsule	PSN	5000f95c-c78d-4150-9a69-0ee2943cf2c3	1
314285	zonisamide 100 MG Oral Capsule	SCD	061fdccc-d08e-4e42-8a32-54afb6c89701	1
314285	zonisamide 100 MG Oral Capsule	SCD	19b059f0-a08a-f75a-e063-6294a90a57db	1
314285	zonisamide 100 MG Oral Capsule	SCD	5000f95c-c78d-4150-9a69-0ee2943cf2c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-042-01	72578004201	100 CAPSULE in 1 BOTTLE (72578-042-01)	100 capsule	2022-07-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, USP	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	6
Zonisamide Capsules, USP	REMEDYREPACK INC.	2026-08-18	HUMAN PRESCRIPTION DRUG LABEL	5
Zonisamide Capsules, USP	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Zonisamide Capsules, USP	Preferred Pharmaceuticals Inc	2025-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
Zonisamide Capsules, USP	Advanced Rx Pharmacy of Tennessee, LLC	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	1