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    NDC 65162-0057-11 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 Amneal Pharmaceuticals LLC. The primary component is RALOXIFENE HYDROCHLORIDE.

    Product Information

    NDC 65162-0057
    Product ID 65162-057_7913189a-ed3c-410d-b290-d78ced778ea5
    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 Amneal Pharmaceuticals LLC
    Pharmaceutical Class Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208206
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0057-11 (65162005711)

    NDC Package Code 65162-057-11
    Billing NDC 65162005711
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11)
    Marketing Start Date 2016-01-20
    NDC Exclude Flag N
    Pricing Information N/A