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    NDC 68462-0410-60 propafenone hydrochloride 425 mg/1 Details

    propafenone hydrochloride 425 mg/1

    propafenone hydrochloride is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is PROPAFENONE HYDROCHLORIDE.

    Product Information

    NDC 68462-0410
    Product ID 68462-410_064ec508-4c51-41fa-929f-0abe45b4779b
    Associated GPIs 35300050006940
    GCN Sequence Number 053541
    GCN Sequence Number Description propafenone HCl CAP ER 12H 425 MG ORAL
    HIC3 A2A
    HIC3 Description ANTIARRHYTHMICS
    GCN 21059
    HICL Sequence Number 004833
    HICL Sequence Number Description PROPAFENONE HCL
    Brand/Generic Generic
    Proprietary Name propafenone hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name propafenone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 425
    Active Ingredient Units mg/1
    Substance Name PROPAFENONE HYDROCHLORIDE
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Antiarrhythmic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205268
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0410-60 (68462041060)

    NDC Package Code 68462-410-60
    Billing NDC 68462041060
    Package 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-410-60)
    Marketing Start Date 2017-09-08
    NDC Exclude Flag N
    Pricing Information N/A