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    NDC 70710-1688-08 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 Zydus Pharmaceuticals USA Inc.. The primary component is FULVESTRANT.

    Product Information

    NDC 70710-1688
    Product ID 70710-1688_75a779e9-12ef-4692-bce5-1e0d916c17af
    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 Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215234
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1688-08 (70710168808)

    NDC Package Code 70710-1688-8
    Billing NDC 70710168808
    Package 2 SYRINGE, GLASS in 1 CARTON (70710-1688-8) / 5 mL in 1 SYRINGE, GLASS (70710-1688-2)
    Marketing Start Date 2021-12-14
    NDC Exclude Flag N
    Pricing Information N/A