Zonisamide

Product NDC: 59651-380
Requested package NDC: 59651-380-82
11-digit product format: 596510380
Labeler code: 59651
Product ID: 59651-380_b43ac632-68f3-43f6-aa79-41429a54e1ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077645
Marketing category: ANDA
Marketing start: 2020-08-17
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

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
unfinished package	package	59651-380	59651-380-82	UNFINISHED	Active or certified unfinished drug listing		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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`

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
A077645-001	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22
A077645-002	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29
A077645-003	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077645-001	AB
A077645-002	AB
A077645-003	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	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-002	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-003	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077645-001	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2005-12-22	`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
2026-02-19 14:30 UTC	2026-02	A077645-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077645-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077645-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077645-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077645-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077645-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077645-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077645-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077645-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077645-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077645-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077645-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077645-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077645-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077645-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077645-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077645-001	AB	1	`8072bd15b7f6…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
459384H98V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314285	Internal RxNorm lookup
403966	Internal RxNorm lookup
403967	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ab0631ca-5339-4570-bc27-f1dd92de1d6f	Available on FDA.report

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
59651-380-01	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	6
59651-380-03	Zonisamide	30 in 1 BOTTLE	CAPSULE	30	6
59651-380-05	Zonisamide	500 in 1 BOTTLE	CAPSULE	500	6
59651-380-60	Zonisamide	60 in 1 BOTTLE	CAPSULE	60	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-380-01	EA - Each	59651-380	0fc3e924-6186-41de-97b7-6d50f0c18720	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-380	ZONISAMIDE CAPSULE [AUROBINDO PHARMA LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20231007_ab0631ca-5339-4570-bc27-f1dd92de1d6f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	597f0a0b-e162-497c-9871-f2b73ebad245	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645
Zonisamide	ZONISAMIDE	Aurobindo Pharma Limited	ab0631ca-5339-4570-bc27-f1dd92de1d6f	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645 ndc (product): 59651-380
Zonisamide	ZONISAMIDE	REMEDYREPACK INC.	994e3ce0-f30b-47b1-aa42-b1ed37fb7c12	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077645 application number: ANDA077645

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	597f0a0b-e162-497c-9871-f2b73ebad245	7
314285	zonisamide 100 MG Oral Capsule	SCD	597f0a0b-e162-497c-9871-f2b73ebad245	7
314285	zonisamide 100 MG Oral Capsule	PSN	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6
403966	zonisamide 25 MG Oral Capsule	PSN	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6
403967	zonisamide 50 MG Oral Capsule	PSN	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6
314285	zonisamide 100 MG Oral Capsule	SCD	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6
403966	zonisamide 25 MG Oral Capsule	SCD	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6
403967	zonisamide 50 MG Oral Capsule	SCD	ab0631ca-5339-4570-bc27-f1dd92de1d6f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-380-82	59651038082	800 CAPSULE in 1 BAG (59651-380-82)	800 capsule	17-AUG-20	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZONISAMIDE CAPSULES USP Rx Only	REMEDYREPACK INC.	2026-04-06	HUMAN PRESCRIPTION DRUG LABEL	7
ZONISAMIDE CAPSULES USP Rx Only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-02-09	Human Prescription Drug Label	6