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    NDC 52427-0288-01 Macrodantin 100 mg/1 Details

    Macrodantin 100 mg/1

    Macrodantin is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almatica Pharma LLC. The primary component is NITROFURANTOIN.

    Product Information

    NDC 52427-0288
    Product ID 52427-288_f96e496b-3557-f5ff-83ef-a3805d766ea6
    Associated GPIs 16800050100120
    GCN Sequence Number 009428
    GCN Sequence Number Description nitrofurantoin macrocrystal CAPSULE 100 MG ORAL
    HIC3 W2F
    HIC3 Description NITROFURAN DERIVATIVES ANTIBACTERIAL AGENTS
    GCN 41820
    HICL Sequence Number 004087
    HICL Sequence Number Description NITROFURANTOIN MACROCRYSTAL
    Brand/Generic Brand
    Proprietary Name Macrodantin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nitrofurantoin macrocrystals
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name NITROFURANTOIN
    Labeler Name Almatica Pharma LLC
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA016620
    Listing Certified Through 2024-12-31

    Package

    NDC 52427-0288-01 (52427028801)

    NDC Package Code 52427-288-01
    Billing NDC 52427028801
    Package 100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01)
    Marketing Start Date 2010-09-27
    NDC Exclude Flag N
    Pricing Information N/A