NDC Code(s) : 59011-751-04, 59011-758-04, 59011-752-04, 59011-750-04, 59011-757-04
Packager : Purdue Pharma LP

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: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, UNSPECIFIED(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59011-751-044 in 1 CARTON 14/02/2011
11 in 1 POUCH
1168 h in 1 PATCH Type 0: Not a Combination Product
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:59011-758
Route of Administration TRANSDERMAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine15 ug in 1 h
Inactive Ingredients
Ingredient Name Strength
ETHYL LEVULINATE(UNII: 7BU24CSS2G)
OLEYL OLEATE(UNII: 3X3L452Y85)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59011-758-044 in 1 CARTON 14/02/2011
11 in 1 POUCH
1168 h in 1 PATCH Type 0: Not a Combination Product
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: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, UNSPECIFIED(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59011-752-044 in 1 CARTON 14/02/2011
11 in 1 POUCH
1168 h in 1 PATCH Type 0: Not a Combination Product
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: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
ETHYL LEVULINATE(UNII: 7BU24CSS2G)
OLEYL OLEATE(UNII: 3X3L452Y85)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59011-750-044 in 1 CARTON 14/02/2011
11 in 1 POUCH
1168 h in 1 PATCH Type 0: Not a Combination Product
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:59011-757
Route of Administration TRANSDERMAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine7.5 ug in 1 h
Inactive Ingredients
Ingredient Name Strength
ETHYL LEVULINATE(UNII: 7BU24CSS2G)
OLEYL OLEATE(UNII: 3X3L452Y85)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59011-757-044 in 1 CARTON 14/02/2011
11 in 1 POUCH
1168 h in 1 PATCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021306 02/14/2011

LABELER - Purdue Pharma LP(932323652)

REGISTRANT - Purdue Pharma LP(932323652)

Establishment
Name Address ID/FEI Business Operations
Lohman Therapie System 787660513 MANUFACTURE(59011-757, 59011-750, 59011-752, 59011-751, 59011-758)

PRINCIPAL DISPLAY PANEL

Butrans® 5 mcg Carton
NDC: 59011–750–04

Butrans 5 mcg carton

Butrans® 5 mcg Pouch
NDC: 59011–750–04

Butrans 5 mcg carton

PRINCIPAL DISPLAY PANEL

Butrans® 7.5 mcg Carton
NDC: 59011–757–04

Butrans 7.5 mcg carton

Butrans® 7.5 mcg Pouch
NDC: 59011–757–04

Butrans 7.5 mcg carton

PRINCIPAL DISPLAY PANEL

Butrans® 10 mcg Carton
NDC: 59011–751–04

Butrans 10 mcg Carton

Butrans® 10 mcg Pouch
NDC: 59011–751–04

Butrans 10 mcg Carton

PRINCIPAL DISPLAY PANEL

Butrans® 15 mcg Carton
NDC: 59011–758–04

Butrans 15 mcg carton

Butrans® 15 mcg Pouch
NDC: 59011–758–04

Butrans 15 mcg carton

PRINCIPAL DISPLAY PANEL

Butrans® 20 mcg Carton
NDC: 59011–752–04

Butrans 20 mcg carton

Butrans® 20 mcg Pouch
NDC: 59011–752–04

Butrans 20 mcg carton