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    NDC 65862-0836-30 Amlodipine, Valsartan and Hydrochlorothiazide 10; 12.5; 160 mg/1; mg/1; mg/1 Details

    Amlodipine, Valsartan and Hydrochlorothiazide 10; 12.5; 160 mg/1; mg/1; mg/1

    Amlodipine, Valsartan and Hydrochlorothiazide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN.

    Product Information

    NDC 65862-0836
    Product ID 65862-836_2427a2ec-4baf-41c6-a39a-070bf61083e2
    Associated GPIs 36994503200330
    GCN Sequence Number 065149
    GCN Sequence Number Description amlodipine/valsartan/hcthiazid TABLET 10MG-160MG ORAL
    HIC3 A4V
    HIC3 Description ANGIOTEN.RECEPTR ANTAG-CALCIUM CHANL BLKR-THIAZIDE
    GCN 22631
    HICL Sequence Number 036305
    HICL Sequence Number Description AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE
    Brand/Generic Generic
    Proprietary Name Amlodipine, Valsartan and Hydrochlorothiazide
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine, Valsartan and Hydrochlorothiazide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10; 12.5; 160
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], In
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206180
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0836-30 (65862083630)

    NDC Package Code 65862-836-30
    Billing NDC 65862083630
    Package 30 TABLET, FILM COATED in 1 BOTTLE (65862-836-30)
    Marketing Start Date 2017-12-19
    NDC Exclude Flag N
    Pricing Information N/A