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    NDC 75987-0031-04 Vimovo 20; 375 mg/1; mg/1 Details

    Vimovo 20; 375 mg/1; mg/1

    Vimovo is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is ESOMEPRAZOLE MAGNESIUM; NAPROXEN.

    Product Information

    NDC 75987-0031
    Product ID 75987-031_500596e1-ef8d-4845-ad4c-1de8fd0ec0a1
    Associated GPIs 66109902440620
    GCN Sequence Number 066329
    GCN Sequence Number Description naproxen/esomeprazole mag TAB IR DR 375MG-20MG ORAL
    HIC3 S2P
    HIC3 Description NSAID,COX INHIBITOR-TYPE AND PROTON-PUMP INHIBITOR
    GCN 28572
    HICL Sequence Number 036964
    HICL Sequence Number Description NAPROXEN/ESOMEPRAZOLE MAGNESIUM
    Brand/Generic Brand
    Proprietary Name Vimovo
    Proprietary Name Suffix n/a
    Non-Proprietary Name Naproxen and Esomeprazole Magnesium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 20; 375
    Active Ingredient Units mg/1; mg/1
    Substance Name ESOMEPRAZOLE MAGNESIUM; NAPROXEN
    Labeler Name Horizon Therapeutics USA, Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022511
    Listing Certified Through 2024-12-31

    Package

    NDC 75987-0031-04 (75987003104)

    NDC Package Code 75987-031-04
    Billing NDC 75987003104
    Package 60 TABLET, DELAYED RELEASE in 1 BOTTLE (75987-031-04)
    Marketing Start Date 2010-07-06
    NDC Exclude Flag N
    Pricing Information N/A