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    NDC 51862-0637-28 Fentanyl Buccal 600 ug/1 Details

    Fentanyl Buccal 600 ug/1

    Fentanyl Buccal is a BUCCAL; SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mayne Pharma. The primary component is FENTANYL CITRATE.

    Product Information

    NDC 51862-0637
    Product ID 51862-637_fae09d4d-1120-e15d-e053-6294a90abb56
    Associated GPIs 65100025100340
    GCN Sequence Number 061496
    GCN Sequence Number Description fentanyl citrate TABLET EFF 600 MCG BUCCAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 97284
    HICL Sequence Number 001747
    HICL Sequence Number Description FENTANYL CITRATE
    Brand/Generic Generic
    Proprietary Name Fentanyl Buccal
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fentanyl Citrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route BUCCAL; SUBLINGUAL
    Active Ingredient Strength 600
    Active Ingredient Units ug/1
    Substance Name FENTANYL CITRATE
    Labeler Name Mayne Pharma
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA021947
    Listing Certified Through 2024-12-31

    Package

    NDC 51862-0637-28 (51862063728)

    NDC Package Code 51862-637-28
    Billing NDC 51862063728
    Package 28 BLISTER PACK in 1 CARTON (51862-637-28) / 1 TABLET in 1 BLISTER PACK (51862-637-01)
    Marketing Start Date 2019-06-14
    NDC Exclude Flag N
    Pricing Information N/A