Zonisamide

Product NDC: 71205-727
Requested package NDC: 71205-727-30
11-digit product format: 712050727
Labeler code: 71205
Product ID: 71205-727_b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA214492
Marketing category: ANDA
Marketing start: 2021-07-09
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214492-001	ZONISAMIDE	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26
A214492-002	ZONISAMIDE	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26
A214492-003	ZONISAMIDE	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214492-001	AB
A214492-002	AB
A214492-003	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 3 · 111 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
2026-09-14 22:38:34	2026-08	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-002	ZONISAMIDE	50MG	CAPSULE / ORAL	AB	2021-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-003	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	2021-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214492-001	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	2021-01-26	`301d65b070ca…`

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
2026-09-14 22:38:34	2026-08	A214492-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214492-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214492-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214492-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214492-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214492-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214492-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214492-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214492-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214492-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214492-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214492-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214492-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214492-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214492-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214492-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214492-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214492-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214492-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214492-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214492-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214492-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214492-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214492-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1	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
71205-727-30	Zonisamide	30 in 1 BOTTLE	CAPSULE	30	1
71205-727-60	Zonisamide	60 in 1 BOTTLE	CAPSULE	60	1
71205-727-90	Zonisamide	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-727-30	EA - Each	71205-727	8d4b9781-c89b-4c9b-876b-eadc75270ca2	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-727	ZONISAMIDE CAPSULE [PROFICIENT RX LP]	1	Current NDC, Legacy NDC, 3 package rows	20221211_b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zonisamide	ZONISAMIDE	Advanced Rx of Tennessee, LLC	0bc550a7-09a7-75e4-e063-6294a90a9fc1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214492 application number: ANDA214492
Zonisamide	ZONISAMIDE	Bryant Ranch Prepack	2d569c8a-844b-44a8-81df-3f9c9300a79c	2023-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214492 application number: ANDA214492
Zonisamide	ZONISAMIDE	Proficient Rx LP	b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214492 application number: ANDA214492 ndc (package): 71205-727-30 ndc (product): 71205-727 ndc11 (package): 71205072730
Zonisamide	ZONISAMIDE	Unichem Pharmaceuticals (USA), Inc.	3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214492 application number: ANDA214492

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	b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1	1
314285	zonisamide 100 MG Oral Capsule	SCD	b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-727-30	71205072730	30 CAPSULE in 1 BOTTLE (71205-727-30)	30 capsule	2022-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules USP, for oral administration Rx only	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	1