Zonegran

Product NDC: 59212-680
11-digit product format: 592120680
Labeler code: 59212
Product ID: 59212-680_66904ccc-bcd1-427c-95ed-bfa633bbf0b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanz Pharma (US) Corp.
Application: NDA020789
Marketing category: NDA
Marketing start: 2000-03-27
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	RLD / RS	Approval date
N020789-001	ZONEGRAN	ZONISAMIDE	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27
N020789-002	ZONEGRAN	ZONISAMIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22
N020789-003	ZONEGRAN	ZONISAMIDE	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020789-001	AB
N020789-003	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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-002	ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2003-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020789-003	ZONEGRAN	25MG	CAPSULE / ORAL	AB	RLD	2003-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020789-001	ZONEGRAN	100MG	CAPSULE / ORAL	AB	RLD, RS	2000-03-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N020789-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020789-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020789-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020789-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020789-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020789-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020789-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020789-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020789-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020789-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020789-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020789-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020789-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020789-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020789-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020789-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020789-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020789-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020789-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020789-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020789-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020789-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020789-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020789-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020789-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020789-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020789-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020789-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020789-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020789-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020789-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020789-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020789-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020789-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020789-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020789-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020789-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020789-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020789-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020789-003	AB	1	`f41ea6bd6efb…`

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: Zonegran
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZONISAMIDE	100 mg/1

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
59212-680-10	Zonegran	100 in 1 BOTTLE	CAPSULE	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-680-10	EA - Each	59212-680	ef6a19cc-5135-4af3-b3cf-138509febe9e	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
HYDROGENATED SOYBEAN OIL	INACTIVE INGREDIENT	A2M91M918C	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONEGRAN (ZONISAMIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59212-680	ZONEGRAN (ZONISAMIDE) CAPSULE [ADVANZ PHARMA (US) CORP.]	11	Current NDC, Legacy NDC, 1 package rows	20241224_d12de43e-3ac3-4335-bc85-70d7366a91eb.zip

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
284408	Zonegran 100 MG Oral Capsule	PSN	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
404725	Zonegran 25 MG Oral Capsule	PSN	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
314285	zonisamide 100 MG Oral Capsule	PSN	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
403966	zonisamide 25 MG Oral Capsule	PSN	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
284408	zonisamide 100 MG Oral Capsule [Zonegran]	SBD	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
404725	zonisamide 25 MG Oral Capsule [Zonegran]	SBD	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
314285	zonisamide 100 MG Oral Capsule	SCD	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
403966	zonisamide 25 MG Oral Capsule	SCD	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
284408	Zonegran 100 MG Oral Capsule	SY	d12de43e-3ac3-4335-bc85-70d7366a91eb	12
404725	Zonegran 25 MG Oral Capsule	SY	d12de43e-3ac3-4335-bc85-70d7366a91eb	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-680-10	59212068010	100 CAPSULE in 1 BOTTLE (59212-680-10)	100 capsule	2000-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZONEGRAN ® (zonisamide) capsules, for oral administration Rx Only	Advanz Pharma (US) Corp. \| Eurofins Pharma Quality Control	2026-09-23	Human Prescription Drug Label	13