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Ethosuximide

Ethosuximide Capsules USP, 250 MG

Approved
Approval ID

85c50760-98cc-4888-b27f-146937acc893

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers
FDA

Epic Pharma, LLC

DUNS: 827915443

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethosuximide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42806-708
Application NumberANDA210654
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethosuximide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2021
FDA Product Classification

INGREDIENTS (11)

GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ETHOSUXIMIDEActive
Quantity: 250 mg in 1 1
Code: 5SEH9X1D1D
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT

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Ethosuximide - FDA Drug Approval Details