Zonisamide

Product NDC: 62756-259
11-digit product format: 627560259
Labeler code: 62756
Product ID: 62756-259_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: 50 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	50 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
62756-259-01	Zonisamide	30 in 1 BOTTLE	CAPSULE	30	10
62756-259-02	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	10
62756-259-03	Zonisamide	100 in 1 BOTTLE	CAPSULE	100	10
62756-259-04	Zonisamide	1000 in 1 BOTTLE	CAPSULE	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-259-02	EA - Each	62756-259	3cd2bb8a-5837-41c8-b2fe-80ecdfb3934b	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 [PHYSICIANS TOTAL CARE, INC.]	2
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	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 [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	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 [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [DIRECTRX]	1
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [DIRECTRX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZONISAMIDE CAPSULE [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZONISAMIDE CAPSULE [DIRECTRX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZONISAMIDE CAPSULE [DIRECTRX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZONISAMIDE CAPSULE [DIRECTRX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZONISAMIDE CAPSULE [DIRECTRX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [DIRECTRX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [DIRECTRX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZONISAMIDE CAPSULE [DIRECTRX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZONISAMIDE CAPSULE [DIRECTRX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZONISAMIDE CAPSULE [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-259	ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Current NDC, Legacy NDC, 4 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
403967	zonisamide 50 MG Oral Capsule	PSN	467a73f0-1cd1-46bf-83b3-ee38badb761c	5
403967	zonisamide 50 MG Oral Capsule	SCD	467a73f0-1cd1-46bf-83b3-ee38badb761c	5
314285	zonisamide 100 MG Oral Capsule	PSN	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
314285	zonisamide 100 MG Oral Capsule	PSN	902a17d4-ce4f-476a-81d8-bb518041c814	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
403967	zonisamide 50 MG Oral Capsule	PSN	062ea00d-ba12-4667-a6e3-7d7a6d82bb7b	1
403967	zonisamide 50 MG Oral Capsule	SCD	062ea00d-ba12-4667-a6e3-7d7a6d82bb7b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-259-01	62756025901	30 CAPSULE in 1 BOTTLE (62756-259-01)	30 capsule	2006-03-17	0000-00-00	No	No	Current
62756-259-02	62756025902	100 CAPSULE in 1 BOTTLE (62756-259-02)	100 capsule	2006-03-17	0000-00-00	No	No	Current
62756-259-03	62756025903	100 CAPSULE in 1 BOTTLE (62756-259-03)	100 capsule	2006-03-17	0000-00-00	No	No	Current
62756-259-04	62756025904	1000 CAPSULE in 1 BOTTLE (62756-259-04)	1000 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	Bryant Ranch Prepack	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	5
ZONISAMIDE	DirectRX	2015-10-26	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#