Zonisamide

Product NDC: 68382-214
11-digit product format: 683820214
Labeler code: 68382
Product ID: 68382-214_61639a39-ae22-47e9-9bc0-97fb0c5c2c2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA077625
Marketing category: ANDA
Marketing start: 2017-11-22
Marketing end: 0000-00-00
Substance: ZONISAMIDE
Active strength: 100 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-214		D	Discontinued by firm	2026-08-17
excluded package	package	68382-214	68382-214-01	D	Discontinued by firm	2026-08-17
excluded package	package	68382-214	68382-214-05	D	Discontinued by firm	2026-08-17
excluded package	package	68382-214	68382-214-10	D	Discontinued by firm	2026-08-17

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 · 48 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	68382-214-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-214-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-214-10	`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	68382-214-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-214-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-214-10	`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	68382-214-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-214-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-214-10	`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	68382-214-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-214-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-214-10	`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	68382-214-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-214-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-214-10	`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	68382-214-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-214-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-214-10	`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	68382-214-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-214-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-214-10	`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	68382-214-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-214-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-214-10	`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	68382-214-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-214-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-214-10	`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	68382-214-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-214-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-214-10	`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	68382-214-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-214-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-214-10	`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	68382-214-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-214-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-214-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077625-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-10-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077625-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077625-001	AB	1	`1e350fbaab3a…`

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

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
68382-214-01	68382021401	100 CAPSULE in 1 BOTTLE (68382-214-01)	100 capsule	2017-11-22	0000-00-00	No	No	Current
68382-214-05	68382021405	500 CAPSULE in 1 BOTTLE (68382-214-05)	500 capsule	2017-11-22	0000-00-00	No	No	Current
68382-214-10	68382021410	1000 CAPSULE in 1 BOTTLE (68382-214-10)	1000 capsule	2017-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules	Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2020-09-17	HUMAN PRESCRIPTION DRUG LABEL	4