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    NDC 65162-0689-88 Nitrofurantoin 25 mg/5mL Details

    Nitrofurantoin 25 mg/5mL

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

    Product Information

    NDC 65162-0689
    Product ID 65162-689_bf73704c-93ce-472e-b17c-4b2f68ade39a
    Associated GPIs 16800050001810
    GCN Sequence Number 009434
    GCN Sequence Number Description nitrofurantoin ORAL SUSP 25 MG/5 ML ORAL
    HIC3 W2F
    HIC3 Description NITROFURAN DERIVATIVES ANTIBACTERIAL AGENTS
    GCN 41870
    HICL Sequence Number 004089
    HICL Sequence Number Description NITROFURANTOIN
    Brand/Generic Generic
    Proprietary Name Nitrofurantoin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nitrofurantoin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 25
    Active Ingredient Units mg/5mL
    Substance Name NITROFURANTOIN
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201679
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0689-88 (65162068988)

    NDC Package Code 65162-689-88
    Billing NDC 65162068988
    Package 230 mL in 1 BOTTLE, GLASS (65162-689-88)
    Marketing Start Date 2011-03-24
    NDC Exclude Flag N
    Pricing Information N/A