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    NDC 16714-0070-02 FULVESTRANT 50 mg/mL Details

    FULVESTRANT 50 mg/mL

    FULVESTRANT is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Northstar Rx, LLC,. The primary component is FULVESTRANT.

    Product Information

    NDC 16714-0070
    Product ID 16714-070_244e8f58-8aba-5ede-0b9d-a566f1021cfb
    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, SOLUTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name FULVESTRANT
    Labeler Name Northstar Rx, 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 ANDA213553
    Listing Certified Through 2024-12-31

    Package

    NDC 16714-0070-02 (16714007002)

    NDC Package Code 16714-070-02
    Billing NDC 16714007002
    Package 2 SYRINGE, GLASS in 1 CARTON (16714-070-02) / 5 mL in 1 SYRINGE, GLASS (16714-070-01)
    Marketing Start Date 2021-08-23
    NDC Exclude Flag N
    Pricing Information N/A