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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

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Zonegran - FDA Drug Approval Details