Label: SOLUTITIONKITS PIMOBENDAN- pimobendan kit

  • Category: BULK INGREDIENT - ANIMAL DRUG
  • DEA Schedule: None
  • Marketing Status: Bulk Ingredient For Animal Drug Compounding

Drug Label Information

Updated July 25, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx ONLY

    NDC 46144-606-01

    SolutionKits™Pimobendan

    Pimobendan 2.5 mg/mL in SolutionKits™ Suspension Vehicle

    FOR VETERINARY COMPOUNDING ONLY

    EACH KIT INCLUDES:

    1 bottle containing Pimobendan Powder equivalent to 1.1g Pimobendan USP for Oral Suspension

    1 bottle containing 440 mL SolutionKits™ Suspension Vehicle provided as a suspending agent for compounding (Contains Artificial Chicken and Marshmallow Flavoring)

    This kit contains 1 funnel

    A.P.I.

    Solutions

    Daphne, AL USA

    14.9 FL OZ (440 mL) as dispensed

  • PRINCIPAL DISPLAY PANEL

    bottle label

    carton label

  • INGREDIENTS AND APPEARANCE
    SOLUTITIONKITS  PIMOBENDAN
    pimobendan kit
    Product Information
    Product TypeItem Code (Source)NDC:46144-606
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46144-606-011 in 1 BOX
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 1.1 g
    Part 21 BOTTLE, PLASTIC 440 mL
    Part 1 of 2
    SOLUTIONKITS  PIMOBENDAN
    pimobendan powder, for suspension
    Product Information
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIMOBENDAN (UNII: 34AP3BBP9T) (PIMOBENDAN - UNII:34AP3BBP9T) PIMOBENDAN1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.1 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING
    Part 2 of 2
    SOLUTIONKITS SUSPENSION VEHICLE 
    oral suspension liquid
    Product Information
    Route of AdministrationNOT APPLICABLE
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1440 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING07/25/2022
    Labeler - API Solutions (831870824)