Search by Drug Name or NDC

    NDC 10135-0732-01 Mexiletine Hydrochloride 250 mg/1 Details

    Mexiletine Hydrochloride 250 mg/1

    Mexiletine Hydrochloride is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Marlex Pharmaceuticals, Inc.. The primary component is MEXILETINE HYDROCHLORIDE.

    Product Information

    NDC 10135-0732
    Product ID 10135-732_09bc0907-5c76-ce4f-e063-6294a90a5b6f
    Associated GPIs 35200025100115
    GCN Sequence Number 000269
    GCN Sequence Number Description mexiletine HCl CAPSULE 250 MG ORAL
    HIC3 A2A
    HIC3 Description ANTIARRHYTHMICS
    GCN 12212
    HICL Sequence Number 000084
    HICL Sequence Number Description MEXILETINE HCL
    Brand/Generic Generic
    Proprietary Name Mexiletine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Mexiletine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 250
    Active Ingredient Units mg/1
    Substance Name MEXILETINE HYDROCHLORIDE
    Labeler Name Marlex Pharmaceuticals, Inc.
    Pharmaceutical Class Antiarrhythmic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213500
    Listing Certified Through 2024-12-31

    Package

    NDC 10135-0732-01 (10135073201)

    NDC Package Code 10135-732-01
    Billing NDC 10135073201
    Package 100 CAPSULE in 1 BOTTLE (10135-732-01)
    Marketing Start Date 2022-02-01
    NDC Exclude Flag N
    Pricing Information N/A