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    NDC 65862-0737-03 Amlodipine and valsartan 5; 160 mg/1; mg/1 Details

    Amlodipine and valsartan 5; 160 mg/1; mg/1

    Amlodipine and valsartan 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; VALSARTAN.

    Product Information

    NDC 65862-0737
    Product ID 65862-737_7b573bca-a494-4c6f-b7e5-d2b35f7c71e0
    Associated GPIs 36993002100310
    GCN Sequence Number 062180
    GCN Sequence Number Description amlodipine besylate/valsartan TABLET 5 MG-160MG ORAL
    HIC3 A4H
    HIC3 Description ANGIOTENSIN RECEPTOR BLOCKR-CALCIUM CHANNEL BLOCKR
    GCN 97962
    HICL Sequence Number 034433
    HICL Sequence Number Description AMLODIPINE BESYLATE/VALSARTAN
    Brand/Generic Generic
    Proprietary Name Amlodipine and valsartan
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine and valsartan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5; 160
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; 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]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206512
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0737-03 (65862073703)

    NDC Package Code 65862-737-03
    Billing NDC 65862073703
    Package 3 BLISTER PACK in 1 CARTON (65862-737-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-737-10)
    Marketing Start Date 2016-04-22
    NDC Exclude Flag N
    Pricing Information N/A