Label: ORBIFLOXACIN powder

  • NDC Code(s): 42662-001-01
  • Packager: KATAYAMA SEIYAKUSYO CO., LTD.
  • Category: BULK INGREDIENT - ANIMAL DRUG
  • DEA Schedule: None
  • Marketing Status: Bulk Ingredient For Animal Drug Compounding

Drug Label Information

Updated December 3, 2020

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  • Principal Display Panel – Drum Label

    ORBIFLOXACIN

    CAUTION

    For manufacturing, processing, or repacking Federal law
    restricts this drug to use by or on the order of a licensed
    veterinarian. Store at 4°C to 25°C, with excursions up to
    40°C.

    LOT NO.: GROSS: kg

    TARE: kg

    RETESTED DATE: NET: kg

    KATAYAMA SEIYAKUSYO CO., LTD. TOYAMA PLANT

    1-3 Yasuuchi, Yatsuo Machi, Toyama 939-2366, Japan

    Principal Display Panel – Drum Label
  • INGREDIENTS AND APPEARANCE
    ORBIFLOXACIN 
    orbifloxacin powder
    Product Information
    Product TypeItem Code (Source)NDC:42662-001
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Orbifloxacin (UNII: 660932TPY6) (Orbifloxacin - UNII:660932TPY6) Orbifloxacin1 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42662-001-0130 kg in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING03/22/2019
    Labeler - KATAYAMA SEIYAKUSYO CO., LTD. (693462848)
    Establishment
    NameAddressID/FEIBusiness Operations
    KATAYAMA SEIYAKUSHO CO.,LTD.693462848API MANUFACTURE, ANALYSIS, LABEL, PACK