Label: DETOMIDINE HYDROCHLORIDE powder

  • NDC Code(s): 64189-8601-0, 64189-8601-1
  • Packager: GRINDEKS Joint Stock Company
  • Category: BULK INGREDIENT - ANIMAL DRUG
  • DEA Schedule: None
  • Marketing Status: bulk ingredient

Drug Label Information

Updated December 21, 2021

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  • WARNINGS AND PRECAUTIONS

    Caution:  For further manufacturing, processing, or repackaging, per 21 CFR 201.122

                   Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

  • STORAGE AND HANDLING

    Storage:  This product is a hygroscopic powder that should be stored in a dry place, protected from light. Keep container tightly closed. Recommend storage temperature 15° to  30°C (59° to 86°F).

  • PRINCIPAL DISPLAY PANEL

    NDC Number: 64189-8601-0                        Country of Origin: Latvia

    DETOMIDINE HYDROCHLORIDE

    (Non-sterile, For Veterinary Use Only)

    Cas Number: 90038-01-0                 VMF Number: 005-865

    Lot Number:_______________         Release Date:____________

    Net Weight:____________grams       Retest Date:_____________ (Month, Year)

    Storage:   This product is a hygroscopic powder that should be stored in a dry place, protected from light.  Keep container tightly closed.  REcommend storage temperature 15° to 30°C (59° to 86°F).

    Caution: For further manufacturing, processing, or repackaging, per 21 CFR 201.122.  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    Grindex

    Manufactured by: JSC GRINDEKS

    53 Krustpils Street, Riga, LV-1057, Latvia

    USA Exclusive Agent

    GDL International, 1805 Oak Ridge Circle Suite 101

    St. Joseph, MO 64506, USA

    image description

  • INGREDIENTS AND APPEARANCE
    DETOMIDINE HYDROCHLORIDE 
    detomidine hydrochloride powder
    Product Information
    Product TypeItem Code (Source)NDC:64189-8601
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DETOMIDINE HYDROCHLORIDE (UNII: 95K4LKB6QE) (DETOMIDINE - UNII:7N8K34P2XH) DETOMIDINE HYDROCHLORIDE1 g  in 1 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64189-8601-01 in 1 BAG
    11000 g in 1 BAG
    2NDC:64189-8601-11 in 1 BAG
    25000 g in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    bulk ingredient06/30/2006
    Labeler - GRINDEKS Joint Stock Company (644702888)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRINDEKS Joint Stock Company644702888api manufacture
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