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    NDC 43386-0490-01 Oxycodone and Acetaminophen 325; 2.5 mg/1; mg/1 Details

    Oxycodone and Acetaminophen 325; 2.5 mg/1; mg/1

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

    Product Information

    NDC 43386-0490
    Product ID 43386-490_19826532-ae1f-490a-9122-6536b110f153
    Associated GPIs 65990002200305
    GCN Sequence Number 013998
    GCN Sequence Number Description oxycodone HCl/acetaminophen TABLET 2.5-325 MG ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 70492
    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; 2.5
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
    Labeler Name Lupin Pharmaceuticals,Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA204407
    Listing Certified Through 2024-12-31

    Package

    NDC 43386-0490-01 (43386049001)

    NDC Package Code 43386-490-01
    Billing NDC 43386049001
    Package 100 TABLET in 1 BOTTLE (43386-490-01)
    Marketing Start Date 2017-02-24
    NDC Exclude Flag N
    Pricing Information N/A