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    NDC 64896-0695-03 Oxymorphone hydrochloride 5 mg/1 Details

    Oxymorphone hydrochloride 5 mg/1

    Oxymorphone hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is OXYMORPHONE HYDROCHLORIDE.

    Product Information

    NDC 64896-0695
    Product ID 64896-695_61a770cc-7bae-4c2f-8db8-b8219c64e681
    Associated GPIs 65100080107405
    GCN Sequence Number 061091
    GCN Sequence Number Description oxymorphone HCl TAB ER 12H 5 MG ORAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 27247
    HICL Sequence Number 001696
    HICL Sequence Number Description OXYMORPHONE HCL
    Brand/Generic Generic
    Proprietary Name Oxymorphone hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Oxymorphone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name OXYMORPHONE HYDROCHLORIDE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA079087
    Listing Certified Through 2024-12-31

    Package

    NDC 64896-0695-03 (64896069503)

    NDC Package Code 64896-695-03
    Billing NDC 64896069503
    Package 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-695-03)
    Marketing Start Date 2013-01-02
    NDC Exclude Flag N
    Pricing Information N/A