Zonisamide
Approved
Approval ID
902a17d4-ce4f-476a-81d8-bb518041c814
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-5789
Application NumberANDA077634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (6)
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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
Zonisamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6221
Application NumberANDA077634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (5)
ZONISAMIDEActive
Quantity: 50 mg in 1 1
Code: 459384H98V
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT