ZONISAMIDE

Product NDC: 61919-917
Requested package NDC: 61919-917-90
11-digit product format: 619190917
Labeler code: 61919
Product ID: 61919-917_e93413f9-dfe8-1b5e-e053-2995a90a2b27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZONISAMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA077634
Marketing category: ANDA
Marketing start: 2019-08-19
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-917	61919-917-90	I	Inactivated by FDA		2026-09-14

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	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 · 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	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077634-001	ZONISAMIDE	25MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077634-002	ZONISAMIDE	50MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077634-003	ZONISAMIDE	100MG	CAPSULE / ORAL		2006-03-17	`caaa826d4ba7…`
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…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-917-30	2026-01-29	C162847	48780-1	49896155-c8f8-586f-e063-e6dba90add90	ZONISAMIDE
61919-917-90	2026-01-29	C162847	48780-1	49896155-c8f8-586f-e063-e6dba90add90	ZONISAMIDE
61919-917-60	2020-01-31	C162847	48780-1	9d75b9d0-9a7b-f424-e053-dadaa90a57ce	ZONISAMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-917-30	ZONISAMIDE	30 in 1 BOTTLE	CAPSULE	30	5
61919-917-90	ZONISAMIDE	90 in 1 BOTTLE	CAPSULE	90	5
61919-917-60	ZONISAMIDE	60 in 1 BOTTLE	CAPSULE	60	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-917-30	EA - Each	61919-917	3d16dd96-c7e7-4310-a25c-54cd0d549fc1	1	2019-09-05
61919-917-60	EA - Each	61919-917	3f86510c-ac2c-4f57-9c00-818ed1b0d17d	1	2017-12-14
61919-917-90	EA - Each	61919-917	d2292fcb-fe52-4d46-95c9-6c71c4353ec3	1	2022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [DIRECT RX]	3
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [DIRECT RX]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZONISAMIDE CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [DIRECT RX]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ZONISAMIDE CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-917	ZONISAMIDE CAPSULE [DIRECT_RX]	5	Legacy NDC, 2 package rows	20240111_907c965e-8faf-53db-e053-2995a90a8cd1.zip
61919-917	ZONISAMIDE CAPSULE [DIRECT RX]	4	Legacy NDC, 1 package rows	20171111_31b97f07-9783-479d-b448-b272610a2f36.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
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	907c965e-8faf-53db-e053-2995a90a8cd1	5
314285	zonisamide 100 MG Oral Capsule	SCD	907c965e-8faf-53db-e053-2995a90a8cd1	5
314285	zonisamide 100 MG Oral Capsule	PSN	31b97f07-9783-479d-b448-b272610a2f36	4
314285	zonisamide 100 MG Oral Capsule	SCD	31b97f07-9783-479d-b448-b272610a2f36	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-917-90	61919091790	90 CAPSULE in 1 BOTTLE (61919-917-90)	90 capsule	2022-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZONISAMIDE	Direct_Rx	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	5
ZONISAMIDE	DIRECT RX	2017-11-10	HUMAN PRESCRIPTION DRUG LABEL	4