ZONISAMIDE

Product NDC: 21695-654
11-digit product format: 216950654
Labeler code: 21695
Product ID: 21695-654_c9c9efaf-983f-4f72-9099-0957fee5396c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZONISAMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA077634
Marketing category: ANDA
Marketing start: 2006-03-17
Marketing end: 0000-00-00
Substance: ZONISAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-654-60	2019-09-24	C162847	48780-1	934fe258-49f5-48b1-e053-8cdaa90a720a	Zonisamide Capsules

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-654-60	ZONISAMIDE	60 in 1 BOTTLE	CAPSULE	60		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-654-60	EA - Each	21695-654	9273d207-e4f5-4735-bdc8-a149fa290c7f	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZONISAMIDE	ACTIVE INGREDIENT	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
ZONISAMIDE	ACTIVE MOIETY	459384H98V	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	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 RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-654	ZONISAMIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 1 package rows	20110920_f89aba5c-bd19-4476-925c-bd7bd34723bb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
459384H98V	ZONISAMIDE	68291-97-4	ZONISAMIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314285	zonisamide 100 MG Oral Capsule	PSN	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
403967	zonisamide 50 MG Oral Capsule	PSN	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
314285	zonisamide 100 MG Oral Capsule	SCD	f89aba5c-bd19-4476-925c-bd7bd34723bb	2
403967	zonisamide 50 MG Oral Capsule	SCD	f89aba5c-bd19-4476-925c-bd7bd34723bb	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-654-60	21695065460	60 in 1 BOTTLE	Historical