Search by Drug Name or NDC

    NDC 63323-0455-01 Morphine Sulfate 5 mg/mL Details

    Morphine Sulfate 5 mg/mL

    Morphine Sulfate 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 MORPHINE SULFATE.

    Product Information

    NDC 63323-0455
    Product ID 63323-455_4347699d-d9de-4f59-a3de-7af661e2e6c9
    Associated GPIs 65100055102012
    GCN Sequence Number 004080
    GCN Sequence Number Description morphine sulfate VIAL 5 MG/ML INJECTION
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 16042
    HICL Sequence Number 001694
    HICL Sequence Number Description MORPHINE SULFATE
    Brand/Generic Generic
    Proprietary Name Morphine Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Morphine Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 5
    Active Ingredient Units mg/mL
    Substance Name MORPHINE SULFATE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category NDA
    Application Number NDA204223
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0455-01 (63323045501)

    NDC Package Code 63323-455-01
    Billing NDC 63323045501
    Package 25 VIAL, SINGLE-DOSE in 1 BOX (63323-455-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-455-00)
    Marketing Start Date 2018-04-10
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 582f42e5-444e-4246-af8c-e7e28097c69a Details

    Revised: 1/2020