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    NDC 70121-1463-02 Fulvestrant 250 mg/5mL Details

    Fulvestrant 250 mg/5mL

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

    Product Information

    NDC 70121-1463
    Product ID 70121-1463_57de7dfe-c139-4710-838f-416643a906d8
    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 250
    Active Ingredient Units mg/5mL
    Substance Name FULVESTRANT
    Labeler Name Amneal Pharmaceuticals 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 ANDA210044
    Listing Certified Through 2024-12-31

    Package

    NDC 70121-1463-02 (70121146302)

    NDC Package Code 70121-1463-2
    Billing NDC 70121146302
    Package 2 SYRINGE, GLASS in 1 CARTON (70121-1463-2) / 5 mL in 1 SYRINGE, GLASS
    Marketing Start Date 2019-03-04
    NDC Exclude Flag N
    Pricing Information N/A