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    NDC 00169-1401-01 Macrilen 60 mg/mg Details

    Macrilen 60 mg/mg

    Macrilen is a ORAL GRANULE, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novo Nordisk. The primary component is MACIMORELIN.

    Product Information

    NDC 00169-1401
    Product ID 0169-1401_73ad2bc1-353a-4b01-b81c-7b276a5670c9
    Associated GPIs 94200062103020
    GCN Sequence Number 078044
    GCN Sequence Number Description macimorelin acetate SOLN RECON 0.5 MG/ML ORAL
    HIC3 P1U
    HIC3 Description METABOLIC FUNCTION DIAGNOSTICS
    GCN 44266
    HICL Sequence Number 044711
    HICL Sequence Number Description MACIMORELIN ACETATE
    Brand/Generic Brand
    Proprietary Name Macrilen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Macimorelin acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GRANULE, FOR SOLUTION
    Route ORAL
    Active Ingredient Strength 60
    Active Ingredient Units mg/mg
    Substance Name MACIMORELIN
    Labeler Name Novo Nordisk
    Pharmaceutical Class Growth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue Receptor Agonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA205598
    Listing Certified Through n/a

    Package

    NDC 00169-1401-01 (00169140101)

    NDC Package Code 0169-1401-01
    Billing NDC 00169140101
    Package 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH
    Marketing Start Date 2022-01-31
    NDC Exclude Flag N
    Pricing Information N/A