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    NDC 75987-0010-72 DUEXIS 26.6; 800 mg/1; mg/1 Details

    DUEXIS 26.6; 800 mg/1; mg/1

    DUEXIS is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is FAMOTIDINE; IBUPROFEN.

    Product Information

    NDC 75987-0010
    Product ID 75987-010_3eae7ae8-f4f3-4cab-8f44-d48b524d3138
    Associated GPIs 66109902320340
    GCN Sequence Number 067901
    GCN Sequence Number Description ibuprofen/famotidine TABLET 800-26.6MG ORAL
    HIC3 S2X
    HIC3 Description NSAID AND HISTAMINE H2 RECEPTOR ANTAGONIST COMB.
    GCN 30547
    HICL Sequence Number 037986
    HICL Sequence Number Description IBUPROFEN/FAMOTIDINE
    Brand/Generic Brand
    Proprietary Name DUEXIS
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ibuprofen and Famotidine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 26.6; 800
    Active Ingredient Units mg/1; mg/1
    Substance Name FAMOTIDINE; IBUPROFEN
    Labeler Name Horizon Therapeutics USA, Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022519
    Listing Certified Through n/a

    Package

    NDC 75987-0010-72 (75987001072)

    NDC Package Code 75987-010-72
    Billing NDC 75987001072
    Package 9 BLISTER PACK in 1 CARTON (75987-010-72) / 3 TABLET, COATED in 1 BLISTER PACK
    Marketing Start Date 2011-12-05
    NDC Exclude Flag N
    Pricing Information N/A