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    NDC 00641-6020-10 Duramorph 0.5 mg/mL Details

    Duramorph 0.5 mg/mL

    Duramorph is a EPIDURAL; INTRATHECAL; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is MORPHINE SULFATE.

    Product Information

    NDC 00641-6020
    Product ID 0641-6020_423b55d6-92db-4e29-a31b-279a6bafbd12
    Associated GPIs 65100055102050
    GCN Sequence Number 052245
    GCN Sequence Number Description morphine sulfate/PF AMPUL 0.5 MG/ML INJECTION
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 19827
    HICL Sequence Number 025277
    HICL Sequence Number Description MORPHINE SULFATE/PF
    Brand/Generic Brand
    Proprietary Name Duramorph
    Proprietary Name Suffix n/a
    Non-Proprietary Name morphine sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route EPIDURAL; INTRATHECAL; INTRAVENOUS
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/mL
    Substance Name MORPHINE SULFATE
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA
    Application Number NDA018565
    Listing Certified Through 2024-12-31

    Package

    NDC 00641-6020-10 (00641602010)

    NDC Package Code 0641-6020-10
    Billing NDC 00641602010
    Package 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01)
    Marketing Start Date 1984-09-18
    NDC Exclude Flag N
    Pricing Information N/A