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    NDC 67457-0311-05 Fulvestrant 50 mg/mL Details

    Fulvestrant 50 mg/mL

    Fulvestrant is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is FULVESTRANT.

    Product Information

    NDC 67457-0311
    Product ID 67457-311_67238290-4068-4ce9-b79c-5425906c3009
    Associated GPIs 21403530002024
    GCN Sequence Number 050307
    GCN Sequence Number Description fulvestrant SYRINGE 250 MG/5ML INTRAMUSC
    HIC3 V1T
    HIC3 Description SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS)
    GCN 17307
    HICL Sequence Number 023523
    HICL Sequence Number Description FULVESTRANT
    Brand/Generic Generic
    Proprietary Name Fulvestrant
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fulvestrant
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name FULVESTRANT
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208811
    Listing Certified Through 2023-12-31

    Package

    NDC 67457-0311-05 (67457031105)

    NDC Package Code 67457-311-05
    Billing NDC 67457031105
    Package 2 SYRINGE, GLASS in 1 CARTON (67457-311-05) / 5 mL in 1 SYRINGE, GLASS (67457-311-00)
    Marketing Start Date 2019-09-09
    NDC Exclude Flag N
    Pricing Information N/A