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    NDC 63629-9191-01 Nitrofurantoin 25; 75 mg/1; mg/1 Details

    Nitrofurantoin 25; 75 mg/1; mg/1

    Nitrofurantoin 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 63629-9191
    Product ID 63629-9191_310440b5-800a-44ad-9f26-24860f30a08b
    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
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nitrofurantoin
    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 ANDA208516
    Listing Certified Through 2023-12-31

    Package

    NDC 63629-9191-01 (63629919101)

    NDC Package Code 63629-9191-1
    Billing NDC 63629919101
    Package 100 CAPSULE in 1 BOTTLE (63629-9191-1)
    Marketing Start Date 2022-08-15
    NDC Exclude Flag N
    Pricing Information N/A