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    NDC 50228-0438-05 Naproxen and esomeprazole magnesium 20; 500 mg/1; mg/1 Details

    Naproxen and esomeprazole magnesium 20; 500 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 ScieGen Pharmaceuticals, Inc. The primary component is ESOMEPRAZOLE MAGNESIUM; NAPROXEN.

    Product Information

    NDC 50228-0438
    Product ID 50228-438_082e1e1e-b056-f989-e063-6394a90a8045
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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; 500
    Active Ingredient Units mg/1; mg/1
    Substance Name ESOMEPRAZOLE MAGNESIUM; NAPROXEN
    Labeler Name ScieGen Pharmaceuticals, 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 ANDA
    Application Number ANDA217738
    Listing Certified Through 2024-12-31

    Package

    NDC 50228-0438-05 (50228043805)

    NDC Package Code 50228-438-05
    Billing NDC 50228043805
    Package 500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05)
    Marketing Start Date 2023-10-11
    NDC Exclude Flag N
    Pricing Information N/A