Is there a generic for Mexiletine hydrochloride?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Mexiletine hydrochloride, referencing the brand MEXITIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mexiletine hydrochloride?

MEXITIL (NDA 018873, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mexiletine hydrochloride are approved?

Mexiletine hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Mexiletine hydrochloride

Mexiletine hydrochloride: 1 brand, 11 generics; first approved Dec 30, 1985; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 11 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

MEXITILRLD

BOEHRINGER INGELHEIMNDA 01887319853 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (11)

MEXILETINE HYDROCHLORIDE

MACLEODS PHARMS LTDANDA 21998720263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

QUAGENANDA 21587620233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

ANNORA PHARMAANDA 21646320223 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

RISINGANDA 21531520223 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

SENORES PHARMSANDA 21408920213 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

INGENUS PHARMS LLCANDA 21435220213 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

CROSSMEDIKA SAANDA 21350020203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

WATSON LABSANDA 07486519983 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Discontinued	—
200MG	CAPSULE	ORAL	Discontinued	—
250MG	CAPSULE	ORAL	Discontinued	—

MEXILETINE HYDROCHLORIDE

WATSON LABSANDA 07471119973 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Discontinued	—
200MG	CAPSULE	ORAL	Discontinued	—
250MG	CAPSULE	ORAL	Discontinued	—

MEXILETINE HYDROCHLORIDE

ANI PHARMSANDA 07445019963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

MEXILETINE HYDROCHLORIDE

TEVAANDA 07437719953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Dec 30, 1985

41 yr 1 mo ago

Most recent approval

Mar 23, 2026

4 mo ago

Approvals span 1985–2026 across 12 FDA applications.

Brand (NDA) 18%

Generic (ANDA) 1192%

Mexiletine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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