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    NDC 52768-0100-03 AMMONIA N-13 260 mCi/mL Details

    AMMONIA N-13 260 mCi/mL

    AMMONIA N-13 is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Precision Nuclear LLC. The primary component is AMMONIA N-13.

    Product Information

    NDC 52768-0100
    Product ID 52768-100_83a25b5d-25e8-408d-89b0-a8eee42663cb
    Associated GPIs
    GCN Sequence Number 080503
    GCN Sequence Number Description ammonia N-13 SYRINGE 3.75-260 INTRAVEN
    HIC3 A6W
    HIC3 Description CARDIOVASCULAR DIAGNOSTICS - RADIOACTIVE
    GCN 47367
    HICL Sequence Number 045976
    HICL Sequence Number Description AMMONIA N-13
    Brand/Generic Generic
    Proprietary Name AMMONIA N-13
    Proprietary Name Suffix n/a
    Non-Proprietary Name AMMONIA N-13
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 260
    Active Ingredient Units mCi/mL
    Substance Name AMMONIA N-13
    Labeler Name Precision Nuclear LLC
    Pharmaceutical Class Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204547
    Listing Certified Through 2024-12-31

    Package

    NDC 52768-0100-03 (52768010003)

    NDC Package Code 52768-100-03
    Billing NDC 52768010003
    Package 3 mL in 1 SYRINGE (52768-100-03)
    Marketing Start Date 2017-10-01
    NDC Exclude Flag N
    Pricing Information N/A