NDC Code(s) : 42858-750-40, 42858-353-40, 42858-493-40, 42858-586-40, 42858-839-40
Packager : Rhodes Pharmaceuticals L.P.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BuprenorphineBuprenorphine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-750
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:42858-750-404 in 1 CARTON 07/05/2017
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 AUTHORIZED GENERIC NDA021306 07/03/2017
BuprenorphineBuprenorphine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-353
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:42858-353-404 in 1 CARTON 07/05/2017
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 AUTHORIZED GENERIC NDA021306 07/03/2017
BuprenorphineBuprenorphine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-493
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:42858-493-404 in 1 CARTON 07/05/2017
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 AUTHORIZED GENERIC NDA021306 07/03/2017
BuprenorphineBuprenorphine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-586
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:42858-586-404 in 1 CARTON 07/05/2017
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 AUTHORIZED GENERIC NDA021306 07/03/2017
BuprenorphineBuprenorphine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-839
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:42858-839-404 in 1 CARTON 07/05/2017
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 AUTHORIZED GENERIC NDA021306 07/03/2017

LABELER - Rhodes Pharmaceuticals L.P.(831928986)

Establishment
Name Address ID/FEI Business Operations
LTS Lohmann Therapy Systems Corp. 787660513 MANUFACTURE(42858-750, 42858-353, 42858-493, 42858-586, 42858-839)

Establishment
Name Address ID/FEI Business Operations
LTS Lohmann Therapie-Systeme AG 342693590 MANUFACTURE(42858-750, 42858-353, 42858-493, 42858-586, 42858-839)

PRINCIPAL DISPLAY PANEL

Contains:
4 Transdermal Systems
One package of 4 Disposal Units

NDC 42858-750-40

Buprenorphine Transdermal System

5 mcg/hour
CIII

ATTENTION
DISPENSER:
The enclosed
Medication Guide
MUST be provided
to the patient
upon dispensing.

Systemic delivery of 5 mcg per hour of buprenorphine for seven days.

Because serious or life-threatening breathing problems could result,
DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:

  • pain that can be treated with immediate-release opioids or
    non-opioid analgesics
  • intermittent (on an as-needed basis) pain

Rx only

PRINCIPAL DISPLAY PANEL - 5 mcg/hour Patch Pouch Carton

PRINCIPAL DISPLAY PANEL

Contains:
4 Transdermal Systems
One package of 4 Disposal Units

NDC 42858-353-40

Buprenorphine Transdermal System

7.5 mcg/hour
CIII

ATTENTION
DISPENSER:
The enclosed
Medication Guide
MUST be provided
to the patient
upon dispensing.

Systemic delivery of 7.5 mcg per hour of buprenorphine for seven days.

Because serious or life-threatening breathing problems could result,
DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:

  • pain that can be treated with immediate-release opioids or
    non-opioid analgesics
  • intermittent (on an as-needed basis) pain

Rx only

for use in
opioid-experienced
patients only

PRINCIPAL DISPLAY PANEL - 7.5 mcg/hour Patch Pouch Carton

PRINCIPAL DISPLAY PANEL

Contains:
4 Transdermal Systems
One package of 4 Disposal Units

NDC 42858-493-40

Buprenorphine Transdermal System

10 mcg/hour
CIII

ATTENTION
DISPENSER:
The enclosed
Medication Guide
MUST be provided
to the patient
upon dispensing.

Systemic delivery of 10 mcg per hour of buprenorphine for seven days.

Because serious or life-threatening breathing problems could result,
DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:

  • pain that can be treated with immediate-release opioids or
    non-opioid analgesics
  • intermittent (on an as-needed basis) pain

Rx only

for use in
opioid-experienced
patients only

PRINCIPAL DISPLAY PANEL - 10 mcg/hour Patch Pouch Carton

PRINCIPAL DISPLAY PANEL

Contains:
4 Transdermal Systems
One package of 4 Disposal Units

NDC 42858-586-40

Buprenorphine Transdermal System

15 mcg/hour
CIII

ATTENTION
DISPENSER:
The enclosed
Medication Guide
MUST be provided
to the patient
upon dispensing.

Systemic delivery of 15 mcg per hour of buprenorphine for seven days.

Because serious or life-threatening breathing problems could result,
DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:

  • pain that can be treated with immediate-release opioids or
    non-opioid analgesics
  • intermittent (on an as-needed basis) pain

Rx only

for use in
opioid-experienced
patients only

PRINCIPAL DISPLAY PANEL - 15 mcg/hour Patch Pouch Carton

PRINCIPAL DISPLAY PANEL

Contains:
4 Transdermal Systems
One package of 4 Disposal Units

NDC 42858-839-40

Buprenorphine Transdermal System

20 mcg/hour
CIII

ATTENTION
DISPENSER:
The enclosed
Medication Guide
MUST be provided
to the patient
upon dispensing.

Systemic delivery of 20 mcg per hour of buprenorphine for seven days.

Because serious or life-threatening breathing problems could result,
DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:

  • pain that can be treated with immediate-release opioids or
    non-opioid analgesics
  • intermittent (on an as-needed basis) pain

Rx only

for use in
opioid-experienced
patients only

PRINCIPAL DISPLAY PANEL - 20 mcg/hour Patch Pouch Carton