SOLUTITIONKITS PIMOBENDAN- pimobendan kit

SolutitionKits by

Drug Labeling and Warnings

SolutitionKits by is a Other medication manufactured, distributed, or labeled by API Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOLUTITIONKITS  PIMOBENDAN
pimobendan kit

Product Information
Product Type		Item Code (Source)	NDC: 46144-606

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46144-606-01	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	1.1 g
Part 2	1 BOTTLE, PLASTIC	440 mL

Part 1 of 2

SOLUTIONKITS  PIMOBENDAN
pimobendan powder, for suspension

Product Information
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIMOBENDAN (UNII: 34AP3BBP9T) (PIMOBENDAN - UNII:34AP3BBP9T)	PIMOBENDAN	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1.1 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING

Part 2 of 2

SOLUTIONKITS SUSPENSION VEHICLE 
oral suspension liquid

Product Information
Route of Administration	NOT APPLICABLE

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		440 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING		07/25/2022

Labeler - API Solutions (831870824)