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
NDC Product Code59212-680
Application NumberNDA020789
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 20, 2021
Generic NameZonisamide
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
NDC Product Code59212-681
Application NumberNDA020789
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 20, 2021
Generic NameZonisamide
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