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    NDC 63323-0806-01 Fentanyl Citrate 0.05 mg/mL Details

    Fentanyl Citrate 0.05 mg/mL

    Fentanyl Citrate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is FENTANYL CITRATE.

    Product Information

    NDC 63323-0806
    Product ID 63323-806_a3532e70-055b-479d-9b5a-bc56b7eb3101
    Associated GPIs 65100025102007 65100025102012 65100025102022 65100025102037 65100025102042
    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, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 0.05
    Active Ingredient Units mg/mL
    Substance Name FENTANYL CITRATE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA210762
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0806-01 (63323080601)

    NDC Package Code 63323-806-01
    Billing NDC 63323080601
    Package 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)
    Marketing Start Date 2019-05-03
    NDC Exclude Flag N
    Pricing Information N/A