Zonegran
ZONEGRAN (zonisamide) capsules, for oral administration Rx Only
Approved
Approval ID
d12de43e-3ac3-4335-bc85-70d7366a91eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
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 Code59212-680
Application NumberNDA020789
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2021
FDA Product Classification
INGREDIENTS (8)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code59212-681
Application NumberNDA020789
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2021
FDA Product Classification
INGREDIENTS (6)
ZONISAMIDEActive
Quantity: 25 mg in 1 1
Code: 459384H98V
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT