Last Updated: June 17, 2026

Details for New Drug Application (NDA): 040506

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NDA 040506 describes ETHOSUXIMIDE, which is a drug marketed by Bionpharma, Epic Pharma Llc, Heritage Pharms Inc, Onesource Specialty, Puracap Pharm Llc, Chartwell Rx, Pharm Assoc, and Teva Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the ETHOSUXIMIDE profile page.

The generic ingredient in ETHOSUXIMIDE is ethosuximide. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethosuximide profile page.

Summary for 040506

Tradename:	ETHOSUXIMIDE
Applicant:	Chartwell Rx
Ingredient:	ethosuximide
Patents:	0

Pharmacology for NDA: 040506

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040506

Anticonvulsants

Suppliers and Packaging for NDA: 040506

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHOSUXIMIDE	ethosuximide	SYRUP;ORAL	040506	ANDA	Chartwell RX, LLC	62135-064	62135-064-47	473 mL in 1 BOTTLE (62135-064-47)
ETHOSUXIMIDE	ethosuximide	SYRUP;ORAL	040506	ANDA	Chartwell Governmental & Specialty RX, LLC.	68999-064	68999-064-24	2 TRAY in 1 BOX (68999-064-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-064-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	Dec 22, 2003	TE:	AA	RLD:	No

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