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    NDC 70408-0239-32 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 Nostrum Laboratories, Inc.. The primary component is NITROFURANTOIN.

    Product Information

    NDC 70408-0239
    Product ID 70408-239_686f8b08-4e54-4cb2-abdd-595c3fb3d16e
    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 Nostrum Laboratories, Inc.
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201355
    Listing Certified Through 2024-12-31

    Package

    NDC 70408-0239-32 (70408023932)

    NDC Package Code 70408-239-32
    Billing NDC 70408023932
    Package 240 mL in 1 BOTTLE, PLASTIC (70408-239-32)
    Marketing Start Date 2012-03-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c4fc70b5-f6eb-417e-8cc9-5b6e8a6e649f Details

    Revised: 6/2021