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    NDC 60846-0301-15 NIZATIDINE 15 mg/mL Details

    NIZATIDINE 15 mg/mL

    NIZATIDINE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is NIZATIDINE.

    Product Information

    NDC 60846-0301
    Product ID 60846-301_3fd0903c-07b8-420b-bdd7-258259d91920
    Associated GPIs 49200040002050
    GCN Sequence Number 057867
    GCN Sequence Number Description nizatidine SOLUTION 150MG/10ML ORAL
    HIC3 Z2D
    HIC3 Description HISTAMINE H2-RECEPTOR INHIBITORS
    GCN 23129
    HICL Sequence Number 004522
    HICL Sequence Number Description NIZATIDINE
    Brand/Generic Generic
    Proprietary Name NIZATIDINE
    Proprietary Name Suffix n/a
    Non-Proprietary Name NIZATIDINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 15
    Active Ingredient Units mg/mL
    Substance Name NIZATIDINE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090576
    Listing Certified Through 2022-12-31

    Package

    NDC 60846-0301-15 (60846030115)

    NDC Package Code 60846-301-15
    Billing NDC 60846030115
    Package 480 mL in 1 BOTTLE (60846-301-15)
    Marketing Start Date 2016-08-12
    NDC Exclude Flag N
    Pricing Information N/A