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    NDC 68382-0122-01 Amlodipine Besylate 5 mg/1 Details

    Amlodipine Besylate 5 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 68382-0122
    Product ID 68382-122_36812bc2-e5a7-4241-95d0-1e015ddbaf29
    Associated GPIs 34000003100330
    GCN Sequence Number 016926
    GCN Sequence Number Description amlodipine besylate TABLET 5 MG ORAL
    HIC3 A9A
    HIC3 Description CALCIUM CHANNEL BLOCKING AGENTS
    GCN 02683
    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 5
    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 68382-0122-01 (68382012201)

    NDC Package Code 68382-122-01
    Billing NDC 68382012201
    Package 100 TABLET in 1 BOTTLE (68382-122-01)
    Marketing Start Date 2007-09-21
    NDC Exclude Flag N
    Pricing Information N/A