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    NDC 70000-0157-02 Leader Ibuprofen PM 38; 200 mg/1; mg/1 Details

    Leader Ibuprofen PM 38; 200 mg/1; mg/1

    Leader Ibuprofen PM is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is DIPHENHYDRAMINE CITRATE; IBUPROFEN.

    Product Information

    NDC 70000-0157
    Product ID 70000-0157_6011b752-50db-4d7d-a4f9-a40e8827eebd
    Associated GPIs 60309902400320
    GCN Sequence Number 062493
    GCN Sequence Number Description ibuprofen/diphenhydramine cit TABLET 200MG-38MG ORAL
    HIC3 S2S
    HIC3 Description ANALGESIC,NSAID-1ST GEN.ANTIHISTAMINE,SEDATIVE CMB
    GCN 98268
    HICL Sequence Number 034634
    HICL Sequence Number Description IBUPROFEN/DIPHENHYDRAMINE CITRATE
    Brand/Generic Generic
    Proprietary Name Leader Ibuprofen PM
    Proprietary Name Suffix n/a
    Non-Proprietary Name diphenhydramine citrate, ibuprofen
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 38; 200
    Active Ingredient Units mg/1; mg/1
    Substance Name DIPHENHYDRAMINE CITRATE; IBUPROFEN
    Labeler Name Cardinal Health 110, LLC. dba Leader
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA079113
    Listing Certified Through 2024-12-31

    Package

    NDC 70000-0157-02 (70000015702)

    NDC Package Code 70000-0157-2
    Billing NDC 70000015702
    Package 1 BOTTLE in 1 CARTON (70000-0157-2) / 80 TABLET, FILM COATED in 1 BOTTLE
    Marketing Start Date 2016-11-23
    NDC Exclude Flag N
    Pricing Information N/A