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    NDC 70534-0002-01 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 HBT Labs, Inc.. The primary component is FULVESTRANT.

    Product Information

    NDC 70534-0002
    Product ID 70534-002_1c0edab9-ab70-46ac-8262-851e910c49db
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 HBT Labs, 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 ANDA209714
    Listing Certified Through 2023-12-31

    Package

    NDC 70534-0002-01 (70534000201)

    NDC Package Code 70534-002-01
    Billing NDC 70534000201
    Package 2 SYRINGE, GLASS in 1 CARTON (70534-002-01) / 5 mL in 1 SYRINGE, GLASS
    Marketing Start Date 2019-11-21
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 074b30fe-dd11-4220-b6d5-9f68a7c09109 Details

    Revised: 8/2020