ZONISAMIDE
Product Information Zonisamide Capsules Rx Only
Approved
Approval ID
d049bfcf-0634-4649-a782-12976ee4c49e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2011
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZONISAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-945
Application NumberANDA077636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZONISAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (8)
ZONISAMIDEActive
Quantity: 25 mg in 1 1
Code: 459384H98V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ZONISAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-990
Application NumberANDA077636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZONISAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (11)
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ZONISAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-946
Application NumberANDA077636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZONISAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (11)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ZONISAMIDEActive
Quantity: 50 mg in 1 1
Code: 459384H98V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT