Label: FLUDEOXYGLUCOSE F18- fludeoxyglucose f18 injection, solution

  • NDC Code(s): 69864-001-30
  • Packager: The Methodist Hospital Research Institute
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 20, 2017

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  • INGREDIENTS AND APPEARANCE
    FLUDEOXYGLUCOSE F18 
    fludeoxyglucose f18 injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69864-001
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D) FLUDEOXYGLUCOSE F-18 0.3 Ci  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69864-001-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 04/23/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA203904 04/23/2012
    Labeler - The Methodist Hospital Research Institute (185641052)
    Registrant - The Methodist Hospital Research Institute (185641052)
    Establishment
    Name Address ID/FEI Business Operations
    The Methodist Hospital Research Institute 185641052 positron emission tomography drug production(69864-001)
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