Search by Drug Name or NDC

    NDC 00591-5019-02 Fulvestrant 250 mg/5mL Details

    Fulvestrant 250 mg/5mL

    Fulvestrant is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is FULVESTRANT.

    Product Information

    NDC 00591-5019
    Product ID 0591-5019_fa2113fa-a281-498e-a127-4feab0e4d481
    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 250
    Active Ingredient Units mg/5mL
    Substance Name FULVESTRANT
    Labeler Name Actavis Pharma, Inc.
    Pharmaceutical Class Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA210063
    Listing Certified Through n/a

    Package

    NDC 00591-5019-02 (00591501902)

    NDC Package Code 0591-5019-02
    Billing NDC 00591501902
    Package 2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) / 5 mL in 1 SYRINGE, GLASS (0591-5019-11)
    Marketing Start Date 2019-08-22
    NDC Exclude Flag N
    Pricing Information N/A