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    NDC 66869-0564-30 SEGLENTIS 56; 44 mg/1; mg/1 Details

    SEGLENTIS 56; 44 mg/1; mg/1

    SEGLENTIS is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Kowa Pharmaceuticals America, Inc.. The primary component is CELECOXIB; TRAMADOL HYDROCHLORIDE.

    Product Information

    NDC 66869-0564
    Product ID 66869-564_badd15b0-400a-4f3a-bf2d-e3d4b87b2348
    Associated GPIs 65995002100320
    GCN Sequence Number 082830
    GCN Sequence Number Description tramadol HCl/celecoxib TABLET 44 MG-56MG ORAL
    HIC3 H3N
    HIC3 Description OPIOID ANALGESIC AND NSAID COMBINATION
    GCN 51517
    HICL Sequence Number 047670
    HICL Sequence Number Description TRAMADOL HCL/CELECOXIB
    Brand/Generic Brand
    Proprietary Name SEGLENTIS
    Proprietary Name Suffix n/a
    Non-Proprietary Name celecoxib and tramadol hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 56; 44
    Active Ingredient Units mg/1; mg/1
    Substance Name CELECOXIB; TRAMADOL HYDROCHLORIDE
    Labeler Name Kowa Pharmaceuticals America, Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]
    DEA Schedule CIV
    Marketing Category NDA
    Application Number NDA213426
    Listing Certified Through 2024-12-31

    Package

    NDC 66869-0564-30 (66869056430)

    NDC Package Code 66869-564-30
    Billing NDC 66869056430
    Package 1 BOTTLE, PLASTIC in 1 CARTON (66869-564-30) / 30 TABLET in 1 BOTTLE, PLASTIC
    Marketing Start Date 2022-01-01
    NDC Exclude Flag N
    Pricing Information N/A