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    NDC 55111-0289-60 Naproxen and esomeprazole magnesium 20; 375 mg/1; mg/1 Details

    Naproxen and esomeprazole magnesium 20; 375 mg/1; mg/1

    Naproxen and esomeprazole magnesium is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is ESOMEPRAZOLE MAGNESIUM; NAPROXEN.

    Product Information

    NDC 55111-0289
    Product ID 55111-289_331f44b3-1c83-c214-7d48-e5d44fc8bd2a
    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 Generic
    Proprietary Name Naproxen and esomeprazole magnesium
    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 Dr. Reddy's Laboratories Limited
    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 ANDA
    Application Number ANDA204206
    Listing Certified Through 2024-12-31

    Package

    NDC 55111-0289-60 (55111028960)

    NDC Package Code 55111-289-60
    Billing NDC 55111028960
    Package 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)
    Marketing Start Date 2020-02-18
    NDC Exclude Flag N
    Pricing Information N/A