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    NDC 55700-0972-05 Fentanyl System 12.5 ug/1 Details

    Fentanyl System 12.5 ug/1

    Fentanyl System is a TRANSDERMAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Quality Care Products, LLC. The primary component is FENTANYL.

    Product Information

    NDC 55700-0972
    Product ID 55700-972_22e0f964-22f3-4222-b432-1b41ea03a113
    Associated GPIs 65100025008610
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Fentanyl System
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fentanyl
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form PATCH
    Route TRANSDERMAL
    Active Ingredient Strength 12.5
    Active Ingredient Units ug/1
    Substance Name FENTANYL
    Labeler Name Quality Care Products, LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA202097
    Listing Certified Through 2023-12-31

    Package

    NDC 55700-0972-05 (55700097205)

    NDC Package Code 55700-972-05
    Billing NDC 55700097205
    Package 1 POUCH in 1 CARTON (55700-972-05) / 5 PATCH in 1 POUCH
    Marketing Start Date 2022-05-09
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL bf6adb75-371d-41c4-83d6-d70d63eea324 Details

    Revised: 8/2022