ZONISAMIDE

Product NDC: 61919-775
11-digit product format: 619190775
Labeler code: 61919
Product ID: 61919-775_ca4069e7-85af-56d3-e053-2a95a90a0227
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZONISAMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA077651
Marketing category: ANDA
Marketing start: 2019-08-13
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: 2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-775		I	Inactivated by FDA	2026-08-03
excluded product	product	61919-775		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-775	61919-775-60	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-775	61919-775-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-775	61919-775-90	I	Inactivated by FDA	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 2 · 89 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-775-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-775-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-775-30	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-775-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-775-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-775-30	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-775-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-775-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-775-30	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-775-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-775-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-775-30	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-775-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-775-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-775-30	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-775-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-775-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-775-30	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-775-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-775-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-775-30	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-775-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-775-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-775-30	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-775-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-775-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-775-30	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-775-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-775-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-775-30	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-775-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-775-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-775-30	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-775-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-775-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-775-30	`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	TE codes	Approval date
A077651-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30
A077651-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30
A077651-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077651-001	AB
A077651-002	AB
A077651-003	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 · 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	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-01-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077651-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077651-001	AB	1	`8072bd15b7f6…`

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
61919-775-30	2023-01-30	C162847	48780-1	f386c649-99d5-0266-e053-dadaa90a7c1a	ZONISAMIDE
61919-775-90	2023-01-30	C162847	48780-1	f386c649-99d5-0266-e053-dadaa90a7c1a	ZONISAMIDE
61919-775-60	2020-01-31	C162847	48780-1	9d75b9d0-cf85-f424-e053-dadaa90a57ce	Zonisamide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-775-30	ZONISAMIDE	30 in 1 BOTTLE	CAPSULE	30	3
61919-775-90	ZONISAMIDE	90 in 1 BOTTLE	CAPSULE	90	3
61919-775-60	Zonisamide	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-775-30	EA - Each	61919-775	e811d695-11ca-4f4c-ae67-160d28d26c88	1	2021-09-07
61919-775-60	EA - Each	61919-775	1f71d95f-e592-4e86-b4c2-497cca798d20	1	2016-09-02
61919-775-90	EA - Each	61919-775	948df912-2703-4b81-9b5f-8da04dabbf9f	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
ZONISAMIDE	ACTIVE MOIETY	459384H98V	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-775	ZONISAMIDE CAPSULE [DIRECT_RX]	3	Legacy NDC, 2 package rows	20210824_9001965b-dbf6-5504-e053-2a95a90a3c43.zip
61919-775	ZONISAMIDE CAPSULE [DIRECT RX]	2	Legacy NDC, 1 package rows	20160923_94c92836-8673-417a-b461-5b3e68c95b5e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	BluePoint Laboratories	345efcc4-6a36-4ddf-8b6c-9c6c844dab0a	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	1a859304-804a-4588-9961-c2e6ae09aadb	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Glenmark Pharmaceuticals Inc., USA	fe15e56e-8b86-4a65-825c-31d37dd81612	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651
Zonisamide	ZONISAMIDE	Proficient Rx LP	85321a9a-08d9-49e4-8c79-86ecfc536613	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077651 application number: ANDA077651

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	9001965b-dbf6-5504-e053-2a95a90a3c43	3
314285	zonisamide 100 MG Oral Capsule	SCD	9001965b-dbf6-5504-e053-2a95a90a3c43	3
314285	zonisamide 100 MG Oral Capsule	PSN	94c92836-8673-417a-b461-5b3e68c95b5e	2
314285	zonisamide 100 MG Oral Capsule	SCD	94c92836-8673-417a-b461-5b3e68c95b5e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-775-30	61919077530	30 CAPSULE in 1 BOTTLE (61919-775-30)	30 capsule	2019-08-13	0000-00-00	No	No	Current
61919-775-60	61919077560	60 in 1 BOTTLE						Historical
61919-775-90	61919077590	90 CAPSULE in 1 BOTTLE (61919-775-90)	90 capsule	2019-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZONISAMIDE	Direct_Rx	2021-08-23	HUMAN PRESCRIPTION DRUG LABEL	3
Zonisamide	Direct Rx	2016-06-22	HUMAN PRESCRIPTION DRUG LABEL	2