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    NDC 42858-0238-50 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 300; 10 mg/1; mg/1 Details

    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 300; 10 mg/1; mg/1

    HYDROCODONE BITARTRATE 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; HYDROCODONE BITARTRATE.

    Product Information

    NDC 42858-0238
    Product ID 42858-238_f6fca35d-725f-4d3a-93cd-604ee8b4c439
    Associated GPIs 65991702100375
    GCN Sequence Number 057726
    GCN Sequence Number Description hydrocodone/acetaminophen TABLET 10MG-300MG ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 22929
    HICL Sequence Number 001730
    HICL Sequence Number Description HYDROCODONE BITARTRATE/ACETAMINOPHEN
    Brand/Generic Generic
    Proprietary Name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
    Proprietary Name Suffix n/a
    Non-Proprietary Name HYDROCODONE BITARTRATE and ACETAMINOPHEN
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 300; 10
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; HYDROCODONE BITARTRATE
    Labeler Name Rhodes Pharmaceuticals L.P.
    Pharmaceutical Class Opioid Agonist [EPC], Opioid Agonists [MoA]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA207808
    Listing Certified Through 2022-12-31

    Package

    NDC 42858-0238-50 (42858023850)

    NDC Package Code 42858-238-50
    Billing NDC 42858023850
    Package 500 TABLET in 1 BOTTLE (42858-238-50)
    Marketing Start Date 2018-07-31
    NDC Exclude Flag N
    Pricing Information N/A