MEXILETINE HYDROCHLORIDE

Product NDC
82012-029
11-digit product format
820120029
Labeler code
82012
Product ID
82012-029_dd924d44-b14d-440c-9670-8faa42422ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mexiletine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Senores Pharmaceuticals, Inc.
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
82012-029-0482012002904100 CAPSULE in 1 BOTTLE (82012-029-04) 100 capsule2021-11-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MEXILETINE HYDROCHLORIDE CAPSULES USP, 150 mg, 200 mg and 250 mgSenores Pharmaceuticals, Inc.2023-06-16HUMAN PRESCRIPTION DRUG LABEL2