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    NDC 68382-0560-30 nitrofurantoin macrocrystals 100 mg/1 Details

    nitrofurantoin macrocrystals 100 mg/1

    nitrofurantoin macrocrystals is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals (USA) Inc.. The primary component is NITROFURANTOIN.

    Product Information

    NDC 68382-0560
    Product ID 68382-560_0d11f48c-867f-471c-a74c-9d50f6a76cfd
    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 Generic
    Proprietary Name nitrofurantoin macrocrystals
    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 Zydus Pharmaceuticals (USA) Inc.
    Pharmaceutical Class Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205005
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0560-30 (68382056030)

    NDC Package Code 68382-560-30
    Billing NDC 68382056030
    Package 10 BLISTER PACK in 1 CARTON (68382-560-30) / 10 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 2018-02-15
    NDC Exclude Flag N
    Pricing Information N/A