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    NDC 36800-0050-27 Topcare Ibuprofen PM 38; 200 mg/1; mg/1 Details

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

    Topcare Ibuprofen PM is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DIPHENHYDRAMINE CITRATE; IBUPROFEN.

    Product Information

    NDC 36800-0050
    Product ID 36800-050_175bd013-714a-4d59-897d-1503cbad48ae
    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 Topcare Ibuprofen PM
    Proprietary Name Suffix n/a
    Non-Proprietary Name diphenhydramine citrate and 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 Topco Associates LLC
    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 36800-0050-27 (36800005027)

    NDC Package Code 36800-050-27
    Billing NDC 36800005027
    Package 1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
    Marketing Start Date 2009-02-24
    NDC Exclude Flag N
    Pricing Information N/A