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    NDC 58602-0809-61 Esomeprazole Magnesium 20 mg/1 Details

    Esomeprazole Magnesium 20 mg/1

    Esomeprazole Magnesium is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is ESOMEPRAZOLE MAGNESIUM DIHYDRATE.

    Product Information

    NDC 58602-0809
    Product ID 58602-809_c9272322-ef75-4eab-b92a-bc8ea73340a4
    Associated GPIs 49270025106520
    GCN Sequence Number 047525
    GCN Sequence Number Description esomeprazole magnesium CAPSULE DR 20 MG ORAL
    HIC3 D4J
    HIC3 Description PROTON-PUMP INHIBITORS
    GCN 12867
    HICL Sequence Number 021607
    HICL Sequence Number Description ESOMEPRAZOLE MAGNESIUM
    Brand/Generic Generic
    Proprietary Name Esomeprazole Magnesium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Esomeprazole Magnesium
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Labeler Name Aurohealth LLC
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209339
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0809-61 (58602080961)

    NDC Package Code 58602-809-61
    Billing NDC 58602080961
    Package 2 BOTTLE in 1 CARTON (58602-809-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
    Marketing Start Date 2017-10-16
    NDC Exclude Flag N
    Pricing Information N/A