MedPath

Ethosuximide

Ethosuximide Capsules, USP

Approved
Approval ID

bfb2be16-9fe1-48bd-b054-25e2b1ed7a20

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 15, 2015

Manufacturers
FDA

Banner Life Sciences LLC.

DUNS: 079579273

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 Code69387-108
Application NumberANDA040430
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethosuximide
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2015
FDA Product Classification

INGREDIENTS (6)

EthosuximideActive
Quantity: 250 mg in 1 1
Code: 5SEH9X1D1D
Classification: ACTIB
Polyethylene GlycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Ethosuximide - FDA Drug Approval Details