BUPRENORPHINE- buprenorphine injection, solution 
PAYLESS COMPOUNDERS, LLC

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Buprenorphine MDV 0.3mg/mL
BUPRENORPHINE 
buprenorphine injection, solution
Product Information
Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-001
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA ScheduleCIII    
Reporting Period20151029-20160429
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
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70022-001-1010 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/11/2015
Labeler - PAYLESS COMPOUNDERS, LLC (031728341)
Establishment
NameAddressID/FEIBusiness Operations
PAYLESS COMPOUNDERS, LLC604160239outsourcing animal drug compounding

Revised: 10/2015
Document Id: dc4509f8-1abd-49ed-8358-30a2824e5bb5
Set id: 7fc0c3fd-5122-43ce-995d-a55a7ea02371
Version: 3
Effective Time: 20151029
 
PAYLESS COMPOUNDERS, LLC