MEXILETINE HYDROCHLORIDE

Product NDC
72162-1784
11-digit product format
721621784
Labeler code
72162
Product ID
72162-1784_19b815db-4a55-462d-a7c1-5fa18ab97789
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
250 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
72162-1784-172162178401100 CAPSULE in 1 BOTTLE (72162-1784-1) 100 capsule2024-04-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MEXILETINE HYDROCHLORIDE CAPSULES, USP Rx onlyBryant Ranch Prepack2024-10-18HUMAN PRESCRIPTION DRUG LABEL102