Zonisamide

Product NDC: 70518-4600
11-digit product format: 705184600
Labeler code: 70518
Product ID: 70518-4600_4e64df76-2a67-31fd-e063-6294a90ab018
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077651
Marketing category: ANDA
Marketing start: 2026-03-31
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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zonisamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZONISAMIDE	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403966	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
50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	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
70518-4600-0	Zonisamide	100 in 1 BOX	CAPSULE	100	2
70518-4600-1	Zonisamide	1 in 1 POUCH	CAPSULE	1	2
70518-4600-2	Zonisamide	50 in 1 BOX	CAPSULE	50	2

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 ndc (product): 70518-4600
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
403966	zonisamide 25 MG Oral Capsule	PSN	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2
403966	zonisamide 25 MG Oral Capsule	SCD	50bb1a0a-a66d-4a13-a456-a10c1b8c8e94	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4600-0	70518460000	100 POUCH in 1 BOX (70518-4600-0) / 1 CAPSULE in 1 POUCH (70518-4600-1)	100 pouch	2026-03-31	No	No	Current
70518-4600-1	70518460001	1 in 1 POUCH					Historical
70518-4600-2	70518460002	50 POUCH in 1 BOX (70518-4600-2) / 1 CAPSULE in 1 POUCH (70518-4600-1)	50 pouch	2026-05-27	0		Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, USP for oral administration	REMEDYREPACK INC.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	2