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    NDC 17478-0030-05 FENTANYL CITRATE 50 ug/mL Details

    FENTANYL CITRATE 50 ug/mL

    FENTANYL CITRATE is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is FENTANYL CITRATE.

    Product Information

    NDC 17478-0030
    Product ID 17478-030_234d5a6d-8cc7-4c4e-87f4-4e3e2c5c90aa
    Associated GPIs 65100025102012 65100025102022
    GCN Sequence Number 041384
    GCN Sequence Number Description fentanyl citrate/PF AMPUL 50 MCG/ML INJECTION
    HIC3 H3H
    HIC3 Description OPIOID ANALGESIC, ANESTHETIC ADJUNCT AGENTS
    GCN 32806
    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, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units ug/mL
    Substance Name FENTANYL CITRATE
    Labeler Name Akorn
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA
    Application Number NDA016619
    Listing Certified Through 2023-12-31

    Package

    NDC 17478-0030-05 (17478003005)

    NDC Package Code 17478-030-05
    Billing NDC 17478003005
    Package 10 AMPULE in 1 CARTON (17478-030-05) / 5 mL in 1 AMPULE
    Marketing Start Date 2012-03-22
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c5d40297-b769-48cc-9f84-f98b7a333507 Details

    Revised: 9/2022