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    NDC 65162-0248-50 Alosetron Hydrochloride 0.5 mg/1 Details

    Alosetron Hydrochloride 0.5 mg/1

    Alosetron 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 ALOSETRON HYDROCHLORIDE.

    Product Information

    NDC 65162-0248
    Product ID 65162-248_bda445ca-01a9-40ee-aaf7-f8d6a321c01d
    Associated GPIs 52554015100310
    GCN Sequence Number 053708
    GCN Sequence Number Description alosetron HCl TABLET 0.5 MG ORAL
    HIC3 D6C
    HIC3 Description IRRITABLE BOWEL SYNDROME AGENTS, 5-HT3 ANTAGONIST
    GCN 21422
    HICL Sequence Number 020953
    HICL Sequence Number Description ALOSETRON HCL
    Brand/Generic Generic
    Proprietary Name Alosetron Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Alosetron Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name ALOSETRON HYDROCHLORIDE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206647
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0248-50 (65162024850)

    NDC Package Code 65162-248-50
    Billing NDC 65162024850
    Package 500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50)
    Marketing Start Date 2017-01-02
    NDC Exclude Flag N
    Pricing Information N/A