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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 215876

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NDA 215876 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Novast Labs, Quagen, Rising, Senores Pharms, Teva, and Watson Labs, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the MEXILETINE HYDROCHLORIDE profile page.

The generic ingredient in MEXILETINE HYDROCHLORIDE is mexiletine hydrochloride. There are five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.

Summary for 215876

Tradename:	MEXILETINE HYDROCHLORIDE
Applicant:	Quagen
Ingredient:	mexiletine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 215876

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Feb 27, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Feb 27, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Feb 27, 2023	TE:	AB	RLD:	No

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