Zonisamide

Product NDC: 43063-932
11-digit product format: 430630932
Labeler code: 43063
Product ID: 43063-932_e6da992a-7745-191e-e053-2995a90a66d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077634
Marketing category: ANDA
Marketing start: 2006-03-17
Marketing end: 0000-00-00
Substance: ZONISAMIDE
Active strength: 25 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43063-932		D	Discontinued by firm		2026-08-03
excluded package	package	43063-932	43063-932-30	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-932-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-932-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-932-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-932-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-932-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-932-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-932-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-932-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-932-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-932-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-932-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-932-30	`557ba5c1ecfa…`	`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-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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-932-30	EA - Each	43063-932	8aa65f3e-1ce7-4e9d-8f47-51b86ee6fa4d	1	2019-02-13

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-932-30	43063093230	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-932-30)	30 capsule	2019-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, for oral administration Rx only	PD-Rx Pharmaceuticals, Inc.	2022-08-22	HUMAN PRESCRIPTION DRUG LABEL	15