Mexiletine Hydrochloride

Product NDC
63629-9290
11-digit product format
636299290
Labeler code
63629
Product ID
63629-9290_bd5bd2a3-e3d8-4183-9e67-0f82da7faba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074450
Marketing category
ANDA
Marketing start
2020-06-22
Marketing end
0000-00-00
Substance
MEXILETINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9290-1EA - Each63629-9290f7df8f6a-0cfc-4939-94e0-29111424ab5312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9290MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Legacy NDC20240116_0cf32b1c-eecd-4270-9cbe-285c7b440d19.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9290-163629929001100 CAPSULE in 1 BOTTLE (63629-9290-1) 100 capsule2022-06-060000-00-00NoNoCurrent