Zonisamide

Product NDC: 50268-816
11-digit product format: 502680816
Labeler code: 50268
Product ID: 50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA077869
Marketing category: ANDA
Marketing start: 2014-07-02
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: 2026-12-31
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
A077869-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31
A077869-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31
A077869-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077869-001	AB
A077869-002	AB
A077869-003	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	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077869-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2006-05-31	`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	A077869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077869-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077869-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077869-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077869-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077869-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077869-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077869-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077869-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077869-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077869-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077869-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077869-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077869-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077869-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077869-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zonisamide
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314285	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
b20a51ef-255e-1eb0-c0e1-461cde46b887	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	Strength	SPL version
50268-816-11	Zonisamide	1 in 1 BLISTER PACK	CAPSULE	1		10
50268-816-15	Zonisamide	50 in 1 BOX	CAPSULE	50		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-816-11	EA - Each	50268-816	0e187df4-bf59-49b1-86fa-2f871edeb38f	1	2015-05-05
50268-816-15	EA - Each	50268-816	7f022a70-20d4-440e-91b9-d1bdf2a70155	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [AVPAK]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [AVPAK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [AVPAK]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZONISAMIDE CAPSULE [AVPAK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [AVPAK]	2
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ZONISAMIDE CAPSULE [AVPAK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [AVPAK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-816	ZONISAMIDE CAPSULE [AVPAK]	9	Current NDC, Legacy NDC, 2 package rows	20250112_b20a51ef-255e-1eb0-c0e1-461cde46b887.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zonisamide	ZONISAMIDE	Cipla USA Inc.	e8f368cb-6a07-4178-95fa-1d5a209171ed	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869
Zonisamide	ZONISAMIDE	AvPAK	b20a51ef-255e-1eb0-c0e1-461cde46b887	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869 ndc (product): 50268-816
zonisamide	ZONISAMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	226d917a-33de-48cc-baf6-bd6a20668341	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869
Zonisamide	ZONISAMIDE	American Health Packaging	7cdd96c4-3263-4c28-86c0-3c24bcef16c1	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869
zonisamide	ZONISAMIDE	Bryant Ranch Prepack	64bd9d6f-8cc0-4151-a78d-9f1437b36875	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869
Zonisamide	ZONISAMIDE	Exelan Pharmaceuticals, Inc.	24284954-0c29-458f-a9f8-97a7ad418ca7	2021-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077869 application number: ANDA077869

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	b20a51ef-255e-1eb0-c0e1-461cde46b887	10
314285	zonisamide 100 MG Oral Capsule	SCD	b20a51ef-255e-1eb0-c0e1-461cde46b887	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-816-11	50268081611	1 in 1 BLISTER PACK						Historical
50268-816-15	50268081615	50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11)	50 blister pack	2014-07-02	0000-00-00	No	No	Current