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Active ingredient

Mexiletine

50 finished FDA listings contain Mexiletine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MEXILETINE HYDROCHLORIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
14
Strengths listed
150 mg/1 · 200 mg/1 · 250 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6926

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 074377TEVA1995-05-166
ANDA 074450ANI PHARMS1996-05-1612
ANDA 213500CROSSMEDIKA SA2020-07-221
ANDA 214352INGENUS PHARMS LLC2021-01-253
ANDA 214089SENORES PHARMS2021-10-0116
ANDA 202111HOSPIRA2022-05-251
ANDA 215315RISING2022-08-264
ANDA 216463ANNORA PHARMA2022-11-094
ANDA 219987MACLEODS PHARMS2026-03-233

Official labeling on DailyMed

Showing the 12 most recent of 28 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.