Zonisamide

Product NDC: 62756-260
11-digit product format: 627560260
Labeler code: 62756
Product ID: 62756-260_d0c9002b-fa32-4ca8-862f-5286746df2cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zonisamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077634
Marketing category: ANDA
Marketing start: 2006-03-17
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

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

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
62756-260-01	Zonisamide	30 in 1 BOTTLE	CAPSULE	30	10
62756-260-02	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	10
62756-260-03	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	10
62756-260-04	Zonisamide	1000 in 1 BOTTLE	CAPSULE	1000	10
62756-260-05	Zonisamide	500 in 1 BOTTLE	CAPSULE	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-260-02	EA - Each	62756-260	ee0da3dc-bdf6-4a55-b73c-24dc09dfa93e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	7
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [DIRECT RX]	3
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [DIRECT RX]	3
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZONISAMIDE CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ZONISAMIDE CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]	3
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-260	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Current NDC, Legacy NDC, 5 package rows	20200818_3164d438-90bf-420a-9a56-5498b987f91c.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
314285	zonisamide 100 MG Oral Capsule	PSN	3164d438-90bf-420a-9a56-5498b987f91c	10
403966	zonisamide 25 MG Oral Capsule	PSN	3164d438-90bf-420a-9a56-5498b987f91c	10
403967	zonisamide 50 MG Oral Capsule	PSN	3164d438-90bf-420a-9a56-5498b987f91c	10
314285	zonisamide 100 MG Oral Capsule	SCD	3164d438-90bf-420a-9a56-5498b987f91c	10
403966	zonisamide 25 MG Oral Capsule	SCD	3164d438-90bf-420a-9a56-5498b987f91c	10
403967	zonisamide 50 MG Oral Capsule	SCD	3164d438-90bf-420a-9a56-5498b987f91c	10
314285	zonisamide 100 MG Oral Capsule	PSN	53ecba6c-0de4-4e11-81d5-6deac79accd5	7
314285	zonisamide 100 MG Oral Capsule	SCD	53ecba6c-0de4-4e11-81d5-6deac79accd5	7
314285	zonisamide 100 MG Oral Capsule	PSN	907c965e-8faf-53db-e053-2995a90a8cd1	5
314285	zonisamide 100 MG Oral Capsule	PSN	812582ce-fc7e-44b1-a428-7faa3701c1b8	5
314285	zonisamide 100 MG Oral Capsule	PSN	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	5
314285	zonisamide 100 MG Oral Capsule	SCD	6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d	5
314285	zonisamide 100 MG Oral Capsule	SCD	907c965e-8faf-53db-e053-2995a90a8cd1	5
314285	zonisamide 100 MG Oral Capsule	SCD	812582ce-fc7e-44b1-a428-7faa3701c1b8	5
314285	zonisamide 100 MG Oral Capsule	PSN	31b97f07-9783-479d-b448-b272610a2f36	4
314285	zonisamide 100 MG Oral Capsule	SCD	31b97f07-9783-479d-b448-b272610a2f36	4
314285	zonisamide 100 MG Oral Capsule	PSN	902a17d4-ce4f-476a-81d8-bb518041c814	2
314285	zonisamide 100 MG Oral Capsule	PSN	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
403967	zonisamide 50 MG Oral Capsule	PSN	902a17d4-ce4f-476a-81d8-bb518041c814	2
403967	zonisamide 50 MG Oral Capsule	PSN	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
314285	zonisamide 100 MG Oral Capsule	SCD	902a17d4-ce4f-476a-81d8-bb518041c814	2
314285	zonisamide 100 MG Oral Capsule	SCD	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
403967	zonisamide 50 MG Oral Capsule	SCD	902a17d4-ce4f-476a-81d8-bb518041c814	2
403967	zonisamide 50 MG Oral Capsule	SCD	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
314285	zonisamide 100 MG Oral Capsule	PSN	4696e856-69c4-4e7e-b76d-d70d85c4b561	1
314285	zonisamide 100 MG Oral Capsule	SCD	4696e856-69c4-4e7e-b76d-d70d85c4b561	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-260-01	62756026001	30 CAPSULE in 1 BOTTLE (62756-260-01)	30 capsule	2006-03-17	0000-00-00	No	No	Current
62756-260-02	62756026002	100 CAPSULE in 1 BOTTLE (62756-260-02)	100 capsule	2006-03-17	0000-00-00	No	No	Current
62756-260-03	62756026003	100 CAPSULE in 1 BOTTLE (62756-260-03)	100 capsule	2006-03-17	0000-00-00	No	No	Current
62756-260-04	62756026004	1000 CAPSULE in 1 BOTTLE (62756-260-04)	1000 capsule	2006-03-17	0000-00-00	No	No	Current
62756-260-05	62756026005	500 CAPSULE in 1 BOTTLE (62756-260-05)	500 capsule	2006-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zonisamide Capsules, for oral administration Rx only	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	11
Zonisamide Capsules, for oral administration Rx only	Preferred Pharmaceuticals, Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	7
ZONISAMIDE	Direct_Rx	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	5
Zonisamide Capsules, for oral administration Rx only	Bryant Ranch Prepack	2023-10-24	HUMAN PRESCRIPTION DRUG LABEL	5
Zonisamide Capsules, for oral administration Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
ZONISAMIDE	DIRECT RX	2017-11-10	HUMAN PRESCRIPTION DRUG LABEL	4
Zonisamide Capsules	STAT Rx USA LLC	2011-10-26	HUMAN PRESCRIPTION DRUG LABEL	1
Zonisamide - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-01-06	HUMAN PRESCRIPTION DRUG LABEL	2
Zonisamide Capsules	Rebel Distributors Corp	2010-11-17	HUMAN PRESCRIPTION DRUG LABEL	2

Zonisamide

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#