NDC Code(s) : 54569-6325-0, 54569-6326-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Butransbuprenorphine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-6325(NDC:59011-751)
Route of Administration TRANSDERMAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine10 ug in 1 h
Inactive Ingredients
Ingredient Name Strength
ETHYL LEVULINATE(UNII: 7BU24CSS2G)
OLEYL OLEATE(UNII: 3X3L452Y85)
POVIDONE(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-6325-04 in 1 CARTON
11 in 1 POUCH
1168 h in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021306 02/14/2011
Butransbuprenorphine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-6326(NDC:59011-752)
Route of Administration TRANSDERMAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine20 ug in 1 h
Inactive Ingredients
Ingredient Name Strength
ETHYL LEVULINATE(UNII: 7BU24CSS2G)
OLEYL OLEATE(UNII: 3X3L452Y85)
POVIDONE(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-6326-04 in 1 CARTON
11 in 1 POUCH
1168 h in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021306 02/14/2011

PRINCIPAL DISPLAY PANEL

Butrans® 10 mcg
NDC 54569-6325-0

Butrans 10 mcg

PRINCIPAL DISPLAY PANEL

Butrans® 20 mcg
NDC 54569-6326-0

Butrans 20 mcg