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    NDC 00641-6247-25 Fentanyl Citrate 50 ug/mL Details

    Fentanyl Citrate 50 ug/mL

    Fentanyl Citrate is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is FENTANYL CITRATE.

    Product Information

    NDC 00641-6247
    Product ID 0641-6247_90765191-e0c4-4ab2-a1e9-7a6a178fcee5
    Associated GPIs 65100025102007
    GCN Sequence Number 041385
    GCN Sequence Number Description fentanyl citrate/PF VIAL 50 MCG/ML INJECTION
    HIC3 H3H
    HIC3 Description OPIOID ANALGESIC, ANESTHETIC ADJUNCT AGENTS
    GCN 32807
    HICL Sequence Number 025386
    HICL Sequence Number Description FENTANYL CITRATE/PF
    Brand/Generic Generic
    Proprietary Name Fentanyl Citrate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fentanyl Citrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units ug/mL
    Substance Name FENTANYL CITRATE
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA
    Application Number NDA019101
    Listing Certified Through 2024-12-31

    Package

    NDC 00641-6247-25 (00641624725)

    NDC Package Code 0641-6247-25
    Billing NDC 00641624725
    Package 25 VIAL in 1 CARTON (0641-6247-25) / 1 mL in 1 VIAL (0641-6247-01)
    Marketing Start Date 2021-03-18
    NDC Exclude Flag N
    Pricing Information N/A