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    NDC 71511-0301-16 QDOLO 5 mg/mL Details

    QDOLO 5 mg/mL

    QDOLO is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Athena Bioscience, LLC. The primary component is TRAMADOL HYDROCHLORIDE.

    Product Information

    NDC 71511-0301
    Product ID 71511-301_0d07f524-71ba-f90f-e063-6394a90a813d
    Associated GPIs 65100095102005
    GCN Sequence Number 081474
    GCN Sequence Number Description tramadol HCl SOLUTION 5 MG/ML ORAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 48598
    HICL Sequence Number 008317
    HICL Sequence Number Description TRAMADOL HCL
    Brand/Generic Brand
    Proprietary Name QDOLO
    Proprietary Name Suffix n/a
    Non-Proprietary Name tramadol hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/mL
    Substance Name TRAMADOL HYDROCHLORIDE
    Labeler Name Athena Bioscience, LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CIV
    Marketing Category NDA
    Application Number NDA214044
    Listing Certified Through 2024-12-31

    Package

    NDC 71511-0301-16 (71511030116)

    NDC Package Code 71511-301-16
    Billing NDC 71511030116
    Package 473 mL in 1 BOTTLE (71511-301-16)
    Marketing Start Date 2020-09-11
    NDC Exclude Flag N
    Pricing Information N/A