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    NDC 00054-0390-41 oxycodone hydrochloride 5 mg/5mL Details

    oxycodone hydrochloride 5 mg/5mL

    oxycodone hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmceuticals USA Inc.. The primary component is OXYCODONE HYDROCHLORIDE.

    Product Information

    NDC 00054-0390
    Product ID 0054-0390_0cb44981-167f-45c3-b2da-4a83f2c2b7d5
    Associated GPIs 65100075102005
    GCN Sequence Number 004224
    GCN Sequence Number Description oxycodone HCl SOLUTION 5 MG/5 ML ORAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 16280
    HICL Sequence Number 001742
    HICL Sequence Number Description OXYCODONE HCL
    Brand/Generic Generic
    Proprietary Name oxycodone hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name oxycodone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/5mL
    Substance Name OXYCODONE HYDROCHLORIDE
    Labeler Name Hikma Pharmceuticals USA Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA204037
    Listing Certified Through 2024-12-31

    Package

    NDC 00054-0390-41 (00054039041)

    NDC Package Code 0054-0390-41
    Billing NDC 00054039041
    Package 15 mL in 1 BOTTLE (0054-0390-41)
    Marketing Start Date 2014-09-04
    NDC Exclude Flag N
    Pricing Information N/A