NDC Code(s) : 35356-607-04, 35356-605-04, 35356-606-04
Packager : Lake Erie Medical & Surgical Supply DBA Quality Care Products 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:35356-607(NDC:59011-750)
Route of Administration TRANSDERMAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine5 ug in 1 h
Inactive Ingredients
Ingredient Name Strength
levulinic acid(UNII: RYX5QG61EI)
oleyl oleate(UNII: 3X3L452Y85)
povidone(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-607-044 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 03/26/2012
Butransbuprenorphine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-605(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
levulinic acid(UNII: RYX5QG61EI)
oleyl oleate(UNII: 3X3L452Y85)
povidone(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-605-044 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 03/26/2012
Butransbuprenorphine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-606(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
levulinic acid(UNII: RYX5QG61EI)
oleyl oleate(UNII: 3X3L452Y85)
povidone(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-606-044 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 03/26/2012

PRINCIPAL DISPLAY PANEL

Image of 5mcg/h Label

PRINCIPAL DISPLAY PANEL

Image of 10mcg/h Label

PRINCIPAL DISPLAY PANEL

Image of 20mcg/h Label