BUPRENORPHINE- buprenorphine solution 
PAYLESS COMPOUNDERS, LLC

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buprenorphine oral solution 100mL
BUPRENORPHINE 
buprenorphine solution
Product Information
Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-010
Route of AdministrationORAL, TRANSMUCOSALDEA ScheduleCIII    
Reporting Period20151002-20160402
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) BUPRENORPHINE0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70022-010-10100 mL in 1 BOTTLE, PLASTIC; Number of Units = 100
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/02/2015
Labeler - PAYLESS COMPOUNDERS, LLC (031728341)
Establishment
NameAddressID/FEIBusiness Operations
PAYLESS COMPOUNDERS, LLC604160239outsourcing animal drug compounding

Revised: 10/2015
Document Id: ec274314-4c4a-4b48-b143-3c291b90a23b
Set id: a1c1f498-e101-467f-b81c-1451c44e7a01
Version: 1
Effective Time: 20151002
 
PAYLESS COMPOUNDERS, LLC