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    NDC 72245-0193-10 Nalocet 300; 2.5 mg/1; mg/1 Details

    Nalocet 300; 2.5 mg/1; mg/1

    Nalocet is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Forte Bio-Pharma LLC. The primary component is ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE.

    Product Information

    NDC 72245-0193
    Product ID 72245-193_0e837595-e684-5b0f-e063-6394a90a425f
    Associated GPIs 65990002200303
    GCN Sequence Number 060726
    GCN Sequence Number Description oxycodone HCl/acetaminophen TABLET 2.5-300 MG ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 26953
    HICL Sequence Number 001741
    HICL Sequence Number Description OXYCODONE HCL/ACETAMINOPHEN
    Brand/Generic Brand
    Proprietary Name Nalocet
    Proprietary Name Suffix n/a
    Non-Proprietary Name oxycodone and acetaminophen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 300; 2.5
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
    Labeler Name Forte Bio-Pharma LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA040608
    Listing Certified Through 2025-12-31

    Package

    NDC 72245-0193-10 (72245019310)

    NDC Package Code 72245-193-10
    Billing NDC 72245019310
    Package 100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10)
    Marketing Start Date 2018-05-23
    NDC Exclude Flag N
    Pricing Information N/A