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    NDC 42858-0104-10 Oxycodone and Acetaminophen 325; 10 mg/1; mg/1 Details

    Oxycodone and Acetaminophen 325; 10 mg/1; mg/1

    Oxycodone and Acetaminophen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rhodes Pharmaceuticals L.P.. The primary component is ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE.

    Product Information

    NDC 42858-0104
    Product ID 42858-104_52c7325e-1d7f-4a2f-9839-eb47cc5b79da
    Associated GPIs 65990002200335
    GCN Sequence Number 048977
    GCN Sequence Number Description oxycodone HCl/acetaminophen TABLET 10MG-325MG ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 14966
    HICL Sequence Number 001741
    HICL Sequence Number Description OXYCODONE HCL/ACETAMINOPHEN
    Brand/Generic Generic
    Proprietary Name Oxycodone and Acetaminophen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Oxycodone and Acetaminophen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 325; 10
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
    Labeler Name Rhodes Pharmaceuticals L.P.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA201278
    Listing Certified Through 2025-12-31

    Package

    NDC 42858-0104-10 (42858010410)

    NDC Package Code 42858-104-10
    Billing NDC 42858010410
    Package 10 BLISTER PACK in 1 CARTON (42858-104-10) / 10 TABLET in 1 BLISTER PACK
    Marketing Start Date 2014-08-28
    NDC Exclude Flag N
    Pricing Information N/A