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    NDC 57483-0740-42 omeprazole 20.6 mg/1 Details

    omeprazole 20.6 mg/1

    omeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by INNOVUS PHARMACEUTICALS, INC.. The primary component is OMEPRAZOLE MAGNESIUM.

    Product Information

    NDC 57483-0740
    Product ID 57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0
    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 omeprazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name omeprazole
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 20.6
    Active Ingredient Units mg/1
    Substance Name OMEPRAZOLE MAGNESIUM
    Labeler Name INNOVUS PHARMACEUTICALS, INC.
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210593
    Listing Certified Through 2024-12-31

    Package

    NDC 57483-0740-42 (57483074042)

    NDC Package Code 57483-740-42
    Billing NDC 57483074042
    Package 3 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01)
    Marketing Start Date 2020-08-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ce5c9fdc-0c50-4315-8f11-e00c9810abd0 Details

    Revised: 8/2020