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    NDC 68382-0123-77 Amlodipine Besylate 10 mg/1 Details

    Amlodipine Besylate 10 mg/1

    Amlodipine Besylate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is AMLODIPINE BESYLATE.

    Product Information

    NDC 68382-0123
    Product ID 68382-123_36812bc2-e5a7-4241-95d0-1e015ddbaf29
    Associated GPIs 34000003100340
    GCN Sequence Number 016927
    GCN Sequence Number Description amlodipine besylate TABLET 10 MG ORAL
    HIC3 A9A
    HIC3 Description CALCIUM CHANNEL BLOCKING AGENTS
    GCN 02682
    HICL Sequence Number 006494
    HICL Sequence Number Description AMLODIPINE BESYLATE
    Brand/Generic Generic
    Proprietary Name Amlodipine Besylate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine Besylate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name AMLODIPINE BESYLATE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078226
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0123-77 (68382012377)

    NDC Package Code 68382-123-77
    Billing NDC 68382012377
    Package 10 BLISTER PACK in 1 CARTON (68382-123-77) / 10 TABLET in 1 BLISTER PACK
    Marketing Start Date 2007-09-21
    NDC Exclude Flag N
    Pricing Information N/A