buprenorphine by PAYLESS COMPOUNDERS, LLC BUPRENORPHINE 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 solution

Product Information
Product Type	ANIMAL COMPOUNDED DRUG	Item Code (Source)	NDC: 70022-010
Route of Administration	ORAL, TRANSMUCOSAL	DEA Schedule	CIII
Reporting Period	20151002-20160402

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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70022-010-10	100 mL in 1 BOTTLE, PLASTIC; Number of Units = 100

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/02/2015

Labeler - PAYLESS COMPOUNDERS, LLC (031728341)

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