BUPRENORPHINE injection, solution

buprenorphine by

Drug Labeling and Warnings

buprenorphine by is a Other medication manufactured, distributed, or labeled by PAYLESS COMPOUNDERS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUPRENORPHINE 
buprenorphine injection, solution

Product Information
Product Type	ANIMAL COMPOUNDED DRUG	Item Code (Source)	NDC: 70022-001
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS	DEA Schedule	CIII
Reporting Period	20151029-20160429

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
MANNITOL (UNII: 3OWL53L36A)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70022-001-10	10 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/11/2015

Labeler - PAYLESS COMPOUNDERS, LLC (031728341)

Establishment
Name	Address	ID/FEI	Business Operations
PAYLESS COMPOUNDERS, LLC		604160239	outsourcing animal drug compounding