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    NDC 70756-0404-51 Nitrofurantoin (monohydrate/macrocrystals) 25; 75 mg/1; mg/1 Details

    Nitrofurantoin (monohydrate/macrocrystals) 25; 75 mg/1; mg/1

    Nitrofurantoin (monohydrate/macrocrystals) is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lifestar Pharma LLC. The primary component is NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE.

    Product Information

    NDC 70756-0404
    Product ID 70756-404_98c85803-fdee-41fa-af1a-98f05ef725d4
    Associated GPIs
    GCN Sequence Number 016598
    GCN Sequence Number Description nitrofurantoin monohyd/m-cryst CAPSULE 100 MG ORAL
    HIC3 W2F
    HIC3 Description NITROFURAN DERIVATIVES ANTIBACTERIAL AGENTS
    GCN 49001
    HICL Sequence Number 006322
    HICL Sequence Number Description NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS
    Brand/Generic Generic
    Proprietary Name Nitrofurantoin (monohydrate/macrocrystals)
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nitrofurantoin (monohydrate/macrocrystals)
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 25; 75
    Active Ingredient Units mg/1; mg/1
    Substance Name NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
    Labeler Name Lifestar Pharma LLC
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA217357
    Listing Certified Through 2024-12-31

    Package

    NDC 70756-0404-51 (70756040451)

    NDC Package Code 70756-404-51
    Billing NDC 70756040451
    Package 500 CAPSULE in 1 BOTTLE (70756-404-51)
    Marketing Start Date 2023-09-14
    NDC Exclude Flag N
    Pricing Information N/A