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    NDC 72000-0120-06 Xenleta 150 mg/15mL Details

    Xenleta 150 mg/15mL

    Xenleta is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nabriva Therapeutics US, Inc.. The primary component is LEFAMULIN ACETATE.

    Product Information

    NDC 72000-0120
    Product ID 72000-120_772b4b36-4627-4087-8a16-c1ed771939c4
    Associated GPIs 16240040102020
    GCN Sequence Number 080130
    GCN Sequence Number Description lefamulin acetate VIAL 150MG/15ML INTRAVEN
    HIC3 W9E
    HIC3 Description PLEUROMUTILIN DERIVATIVES
    GCN 46827
    HICL Sequence Number 045961
    HICL Sequence Number Description LEFAMULIN ACETATE
    Brand/Generic Brand
    Proprietary Name Xenleta
    Proprietary Name Suffix n/a
    Non-Proprietary Name lefamulin acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 150
    Active Ingredient Units mg/15mL
    Substance Name LEFAMULIN ACETATE
    Labeler Name Nabriva Therapeutics US, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA211673
    Listing Certified Through 2024-12-31

    Package

    NDC 72000-0120-06 (72000012006)

    NDC Package Code 72000-120-06
    Billing NDC 72000012006
    Package 6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) / 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)
    Marketing Start Date 2019-09-09
    NDC Exclude Flag N
    Pricing Information N/A