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    NDC 00078-0489-15 Exforge 10; 160 mg/1; mg/1 Details

    Exforge 10; 160 mg/1; mg/1

    Exforge is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is AMLODIPINE BESYLATE; VALSARTAN.

    Product Information

    NDC 00078-0489
    Product ID 0078-0489_23189575-6ec8-43d3-b630-f2ffcec0c236
    Associated GPIs 36993002100330
    GCN Sequence Number 062181
    GCN Sequence Number Description amlodipine besylate/valsartan TABLET 10MG-160MG ORAL
    HIC3 A4H
    HIC3 Description ANGIOTENSIN RECEPTOR BLOCKR-CALCIUM CHANNEL BLOCKR
    GCN 97963
    HICL Sequence Number 034433
    HICL Sequence Number Description AMLODIPINE BESYLATE/VALSARTAN
    Brand/Generic Brand
    Proprietary Name Exforge
    Proprietary Name Suffix n/a
    Non-Proprietary Name amlodipine besylate and valsartan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10; 160
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; VALSARTAN
    Labeler Name Novartis Pharmaceuticals Corporation
    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 NDA
    Application Number NDA021990
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0489-15 (00078048915)

    NDC Package Code 0078-0489-15
    Billing NDC 00078048915
    Package 30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15)
    Marketing Start Date 2007-06-20
    NDC Exclude Flag N
    Pricing Information N/A