Search by Drug Name or NDC

    NDC 68001-0441-55 Omeprazole 20 mg/1 Details

    Omeprazole 20 mg/1

    Omeprazole is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is OMEPRAZOLE.

    Product Information

    NDC 68001-0441
    Product ID 68001-441_0486dc89-1bf1-8e37-e063-6394a90a9aa7
    Associated GPIs 49270060000620
    GCN Sequence Number 054334
    GCN Sequence Number Description omeprazole TABLET DR 20 MG ORAL
    HIC3 D4J
    HIC3 Description PROTON-PUMP INHIBITORS
    GCN 22228
    HICL Sequence Number 004673
    HICL Sequence Number Description OMEPRAZOLE
    Brand/Generic Generic
    Proprietary Name Omeprazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Omeprazole
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name OMEPRAZOLE
    Labeler Name BluePoint Laboratories
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207740
    Listing Certified Through 2024-12-31

    Package

    NDC 68001-0441-55 (68001044155)

    NDC Package Code 68001-441-55
    Billing NDC 68001044155
    Package 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55)
    Marketing Start Date 2020-06-19
    NDC Exclude Flag N
    Pricing Information N/A