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    NDC 42358-0103-10 Levorphanol Tartrate 3 mg/1 Details

    Levorphanol Tartrate 3 mg/1

    Levorphanol Tartrate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sentynl Therapeutics, Inc.. The primary component is LEVORPHANOL TARTRATE.

    Product Information

    NDC 42358-0103
    Product ID 42358-103_2c7b8406-2c79-49ee-9a96-8aa29c5af444
    Associated GPIs 65100040100310
    GCN Sequence Number 079449
    GCN Sequence Number Description levorphanol tartrate TABLET 3 MG ORAL
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 45941
    HICL Sequence Number 001743
    HICL Sequence Number Description LEVORPHANOL TARTRATE
    Brand/Generic Generic
    Proprietary Name Levorphanol Tartrate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Levorphanol Tartrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 3
    Active Ingredient Units mg/1
    Substance Name LEVORPHANOL TARTRATE
    Labeler Name Sentynl Therapeutics, Inc.
    Pharmaceutical Class Full Opioid Agonists [MoA], Opioid Agonist [EPC]
    DEA Schedule CII
    Marketing Category ANDA
    Application Number ANDA074278
    Listing Certified Through n/a

    Package

    NDC 42358-0103-10 (42358010310)

    NDC Package Code 42358-103-10
    Billing NDC 42358010310
    Package 100 TABLET in 1 BOTTLE, PLASTIC (42358-103-10)
    Marketing Start Date 2018-06-18
    NDC Exclude Flag N
    Pricing Information N/A