Zonisamide
Zonisamide Capsules, for oral administration Rx only
Approved
Approval ID
3164d438-90bf-420a-9a56-5498b987f91c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 24, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-259
Application NumberANDA077634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2020
FDA Product Classification
INGREDIENTS (13)
ZONISAMIDEActive
Quantity: 50 mg in 1 1
Code: 459384H98V
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Zonisamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-260
Application NumberANDA077634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2020
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Zonisamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-258
Application NumberANDA077634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2020
FDA Product Classification
INGREDIENTS (13)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ZONISAMIDEActive
Quantity: 25 mg in 1 1
Code: 459384H98V
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT