ZONISADE

Product NDC: 52652-8001
11-digit product format: 526528001
Labeler code: 52652
Product ID: 52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZONISAMIDE
Dosage form: SUSPENSION
Route: ORAL
Labeler: Azurity Pharmaceuticals, Inc.
Application: NDA214273
Marketing category: NDA
Marketing start: 2022-07-15
Substance: ZONISAMIDE
Active strength: 100 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214273-001	ZONISADE	ZONISAMIDE	100MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-07-15

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214273-001	11478456	2038-08-18	U-3458		2022-10-26
N214273-001	11529333	2038-08-18		Drug product	2022-12-27
N214273-001	12491179	2038-08-18		Drug product	2025-12-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214273-001	ZONISADE	100MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-07-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214273-001	12491179	2038-08-18		Drug product	2025-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214273-001	11529333	2038-08-18		Drug product	2022-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214273-001	11478456	2038-08-18	U-3458		2022-10-26	`a67488948f0b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZONISAMIDE	100 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2606782	Internal RxNorm lookup
2606788	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
ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	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
52652-8001-1	ZONISADE	1 in 1 CARTON	SUSPENSION	1		3
52652-8001-1	ZONISADE	150 mL in 1 BOTTLE	SUSPENSION	150		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52652-8001-1	ML - Milliliter	52652-8001	6e84684b-887a-4ae3-bdd0-90b697d24c91	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52652-8001	ZONISADE (ZONISAMIDE) SUSPENSION [AZURITY PHRAMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20230615_ac16fa15-32e9-4f92-8bc6-d8d41ae002c6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZONISADE	ZONISAMIDE	Azurity Pharmaceuticals, Inc.	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214273 application number: NDA214273 ndc (product): 52652-8001

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
2606788	ZONISADE 100 MG in 5 mL Oral Suspension	PSN	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606782	zonisamide 100 MG in 5 mL Oral Suspension	PSN	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606788	zonisamide 20 MG/ML Oral Suspension [Zonisade]	SBD	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606782	zonisamide 20 MG/ML Oral Suspension	SCD	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606788	Zonisade 100 MG per 5 ML Oral Suspension	SY	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606788	Zonisade 20 MG/ML Oral Suspension	SY	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3
2606782	zonisamide 100 MG per 5 ML Oral Suspension	SY	ac16fa15-32e9-4f92-8bc6-d8d41ae002c6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52652-8001-1	52652800101	1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE	1 bottle	2022-07-15	0000-00-00	No	No	Current