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    NDC 43386-0083-09 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 in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is AMLODIPINE BESYLATE; VALSARTAN.

    Product Information

    NDC 43386-0083
    Product ID 43386-083_8d66a9ba-050e-4993-939b-f2c858760a0c
    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
    Route ORAL
    Active Ingredient Strength 5; 160
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; VALSARTAN
    Labeler Name Lupin Pharmaceuticals,Inc.
    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 ANDA202829
    Listing Certified Through 2024-12-31

    Package

    NDC 43386-0083-09 (43386008309)

    NDC Package Code 43386-083-09
    Billing NDC 43386008309
    Package 90 TABLET in 1 BOTTLE (43386-083-09)
    Marketing Start Date 2015-03-30
    NDC Exclude Flag N
    Pricing Information N/A