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    NDC 71610-0053-60 Raloxifene hydrochloride 60 mg/1 Details

    Raloxifene hydrochloride 60 mg/1

    Raloxifene hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is RALOXIFENE HYDROCHLORIDE.

    Product Information

    NDC 71610-0053
    Product ID 71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fd
    Associated GPIs 30053060100320
    GCN Sequence Number 037022
    GCN Sequence Number Description raloxifene HCl TABLET 60 MG ORAL
    HIC3 P4L
    HIC3 Description BONE RESORPTION INHIBITORS
    GCN 59011
    HICL Sequence Number 016917
    HICL Sequence Number Description RALOXIFENE HCL
    Brand/Generic Generic
    Proprietary Name Raloxifene hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Raloxifene hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 60
    Active Ingredient Units mg/1
    Substance Name RALOXIFENE HYDROCHLORIDE
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206384
    Listing Certified Through 2024-12-31

    Package

    NDC 71610-0053-60 (71610005360)

    NDC Package Code 71610-053-60
    Billing NDC 71610005360
    Package 90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60)
    Marketing Start Date 2018-04-26
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 6fd63a06-5bc5-4c50-9b85-b09c89100b80 Details

    Revised: 4/2018