MEXILETINE HYDROCHLORIDE

Product NDC
71335-2928
11-digit product format
713352928
Labeler code
71335
Product ID
71335-2928_59bf343f-e466-410a-9918-43a88bc817a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mexiletine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214089
Marketing category
ANDA
Marketing start
2021-11-29
Substance
MEXILETINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
606D60IS38MEXILETINE HYDROCHLORIDE5370-01-4MEXILETINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2928-171335292801100 CAPSULE in 1 BOTTLE (71335-2928-1) 100 capsule2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MEXILETINE HYDROCHLORIDE CAPSULES, USP Rx onlyBryant Ranch Prepack2025-11-06HUMAN PRESCRIPTION DRUG LABEL100