MEXILETINE HYDROCHLORIDE

Product NDC
63629-9181
11-digit product format
636299181
Labeler code
63629
Product ID
63629-9181_e4e4a99f-c012-4701-9df1-dbf824017a41
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
63629-9181-163629918101100 CAPSULE in 1 BOTTLE (63629-9181-1) 100 capsule2022-02-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MEXILETINE HYDROCHLORIDE CAPSULES, USP Rx onlyBryant Ranch Prepack2023-10-24HUMAN PRESCRIPTION DRUG LABEL102