Zonisamide
Zonisamide Capsules USP Rx Only
Approved
Approval ID
b20a51ef-255e-1eb0-c0e1-461cde46b887
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 1
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 Code50268-816
Application NumberANDA077869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT