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    NDC 71770-0200-10 PHEBURANE Details

    PHEBURANE

    PHEBURANE is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medunik USA. The primary component is .

    Product Information

    NDC 71770-0200
    Product ID 71770-200_36fd0ef3-2ee0-427c-9670-f59e2c7b67dc
    Associated GPIs
    GCN Sequence Number 072495
    GCN Sequence Number Description sodium phenylbutyrate GRANULES 483 MG/G ORAL
    HIC3 D9A
    HIC3 Description AMMONIA INHIBITORS
    GCN 36733
    HICL Sequence Number 011317
    HICL Sequence Number Description SODIUM PHENYLBUTYRATE
    Brand/Generic Brand
    Proprietary Name PHEBURANE
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sodium phenylbutyrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name Medunik USA
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA216513
    Listing Certified Through 2024-12-31

    Package

    NDC 71770-0200-10 (71770020010)

    NDC Package Code 71770-200-10
    Billing NDC 71770020010
    Package 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10)
    Marketing Start Date 2022-08-26
    NDC Exclude Flag N
    Pricing Information N/A