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    NDC 70518-1087-01 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 REMEDYREPACK INC.. The primary component is NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE.

    Product Information

    NDC 70518-1087
    Product ID 70518-1087_0918baa1-54cf-162b-e063-6294a90a6af9
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 REMEDYREPACK INC.
    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 70518-1087-01 (70518108701)

    NDC Package Code 70518-1087-1
    Billing NDC 70518108701
    Package 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-1)
    Marketing Start Date 2018-08-16
    NDC Exclude Flag N
    Pricing Information N/A