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    NDC 72245-0648-50 Prolate 300; 10 mg/5mL; mg/5mL Details

    Prolate 300; 10 mg/5mL; mg/5mL

    Prolate is a ORAL SOLUTION 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 72245-0648
    Product ID 72245-648_0e837595-e685-5b0f-e063-6394a90a425f
    Associated GPIs 65990002202020
    GCN Sequence Number 082012
    GCN Sequence Number Description oxycodone HCl/acetaminophen SOLUTION 10-300MG/5 ORAL
    HIC3 H3U
    HIC3 Description OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS
    GCN 49308
    HICL Sequence Number 001741
    HICL Sequence Number Description OXYCODONE HCL/ACETAMINOPHEN
    Brand/Generic Brand
    Proprietary Name Prolate
    Proprietary Name Suffix n/a
    Non-Proprietary Name oxycodone hydrochloride and acetaminophen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 300; 10
    Active Ingredient Units mg/5mL; mg/5mL
    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 ANDA202142
    Listing Certified Through 2025-12-31

    Package

    NDC 72245-0648-50 (72245064850)

    NDC Package Code 72245-648-50
    Billing NDC 72245064850
    Package 500 mL in 1 BOTTLE, PLASTIC (72245-648-50)
    Marketing Start Date 2020-03-01
    NDC Exclude Flag N
    Pricing Information N/A