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    NDC 76045-0121-11 Dilaudid 0.2 mg/mL Details

    Dilaudid 0.2 mg/mL

    Dilaudid is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is HYDROMORPHONE HYDROCHLORIDE.

    Product Information

    NDC 76045-0121
    Product ID 76045-121_d2fe0d3b-8eb6-4e54-8418-642f330abbf7
    Associated GPIs 65100035102002
    GCN Sequence Number 081024
    GCN Sequence Number Description hydromorphone HCl/PF SYRINGE 0.2 MG/ML INJECTION
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 48024
    HICL Sequence Number 034805
    HICL Sequence Number Description HYDROMORPHONE HCL/PF
    Brand/Generic Brand
    Proprietary Name Dilaudid
    Proprietary Name Suffix n/a
    Non-Proprietary Name Hydromorphone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 0.2
    Active Ingredient Units mg/mL
    Substance Name HYDROMORPHONE HYDROCHLORIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA
    Application Number NDA019034
    Listing Certified Through 2025-12-31

    Package

    NDC 76045-0121-11 (76045012111)

    NDC Package Code 76045-121-11
    Billing NDC 76045012111
    Package 10 SYRINGE in 1 CARTON (76045-121-11) / 1 mL in 1 SYRINGE (76045-121-01)
    Marketing Start Date 2020-01-16
    NDC Exclude Flag N
    Pricing Information N/A