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    NDC 72187-0102-03 ORSERDU 345 mg/1 Details

    ORSERDU 345 mg/1

    ORSERDU is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Stemline Therapeutics, Inc.. The primary component is ELACESTRANT.

    Product Information

    NDC 72187-0102
    Product ID 72187-0102_8195fa6c-91ac-4fe6-af1b-33881aae7e4c
    Associated GPIs
    GCN Sequence Number 084359
    GCN Sequence Number Description elacestrant HCl TABLET 345 MG ORAL
    HIC3 V1T
    HIC3 Description SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS)
    GCN 53629
    HICL Sequence Number 048658
    HICL Sequence Number Description ELACESTRANT HCL
    Brand/Generic Brand
    Proprietary Name ORSERDU
    Proprietary Name Suffix n/a
    Non-Proprietary Name Elacestrant
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 345
    Active Ingredient Units mg/1
    Substance Name ELACESTRANT
    Labeler Name Stemline Therapeutics, Inc.
    Pharmaceutical Class Breast Cancer Resistance Protein Inhibitors [MoA], Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA217639
    Listing Certified Through 2024-12-31

    Package

    NDC 72187-0102-03 (72187010203)

    NDC Package Code 72187-0102-3
    Billing NDC 72187010203
    Package 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3)
    Marketing Start Date 2023-01-27
    NDC Exclude Flag N
    Pricing Information N/A