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    NDC 63629-1748-03 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 Bryant Ranch Prepack. The primary component is NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE.

    Product Information

    NDC 63629-1748
    Product ID 63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8
    Associated GPIs 16800050150120
    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 Bryant Ranch Prepack
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077066
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-1748-03 (63629174803)

    NDC Package Code 63629-1748-3
    Billing NDC 63629174803
    Package 30 CAPSULE in 1 BOTTLE (63629-1748-3)
    Marketing Start Date 2008-12-16
    NDC Exclude Flag N
    Pricing Information N/A