BUPRENORPHINE- buprenorphine injection, solution 
BUPRENORPHINE- buprenorphine solution 
PAYLESS COMPOUNDERS, LLC
Reference Label Set Id: 8081ccb8-1b38-4673-a9dd-0fb18fa6038a

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Buprenorphine MDV 0.3mg/mL

buprenorphine inj MDV 0.6mg/mL

buprenorphine oral solution 30mL

buprenorphine oral solution 100mL
BUPRENORPHINE 
buprenorphine injection, solution
Product Information
Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-001
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA ScheduleCIII    
Reporting Period20241231-20250630
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)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 other
BUPRENORPHINE 
buprenorphine solution
Product Information
Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-004
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA ScheduleCIII    
Reporting Period20241231-20250630
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)BUPRENORPHINE0.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MANNITOL (UNII: 3OWL53L36A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70022-004-1010 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
BUPRENORPHINE 
buprenorphine solution
Product Information
Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-010
Route of AdministrationORAL, TRANSMUCOSALDEA ScheduleCIII    
Reporting Period20241231-20250630
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)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:70022-010-0330 mL in 1 BOTTLE, PLASTIC; Number of Units = 30
2NDC: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 other
Labeler - PAYLESS COMPOUNDERS, LLC (031728341)
Establishment
NameAddressID/FEIBusiness Operations
PAYLESS COMPOUNDERS, LLC604160239outsourcing animal drug compounding

Revised: 12/2024
Document Id: d2d6c592-d36a-4ec8-bf42-217e9f4c4193
Set id: a1c1f498-e101-467f-b81c-1451c44e7a01
Version: 10
Effective Time: 20241211
 
PAYLESS COMPOUNDERS, LLC