MedPath

Zarontin

Zarontin® (Ethosuximide Capsules, USP)

Approved
Approval ID

0e008f33-70a1-4bc6-b3a0-d45214418ab6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2023

Manufacturers
FDA

Parke-Davis Div of Pfizer Inc

DUNS: 829076962

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 Code0071-0237
Application NumberNDA012380
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ethosuximide
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification

INGREDIENTS (7)

ETHOSUXIMIDEActive
Quantity: 250 mg in 1 1
Code: 5SEH9X1D1D
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Zarontin - FDA Drug Approval Details