FENTANYL- fentanyl patch 
Mylan Technologies Inc.

----------

PRINCIPAL DISPLAY PANEL – 12 microgram/hour

12 microgram/hour Carton Label - UK
12 microgram/hour Carton Label - Belgium
12 microgram/hour Carton Label - Sweden
12 microgram/hour Carton Label - Czech
12 microgram/hour Carton Label - Greece
12 microgram/hour Carton Label - Denmark
12 microgram/hour Carton Label - Netherlands
12 microgram/hour Carton Label - France
12 microgram/hour Carton Label - Portugal

PRINCIPAL DISPLAY PANEL – 25 microgram/hour

25 microgram/hour Carton Label - UK
25 microgram/hour Carton Label - Belgium
25 microgram/hour Carton Label - Germany
25 microgram/hour Carton Label - Sweden
25 microgram/hour Carton Label - Czech
25 microgram/hour Carton Label - Greece
25 microgram/hour Carton Label - Denmark
25 microgram/hour Carton Label - Netherlands
25 microgram/hour Carton Label - France
25 microgram/hour Carton Label - Portugal
25 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 50 microgram/hour

50 microgram/hour Carton Label - UK
50 microgram/hour Carton Label - Belgium
50 microgram/hour Carton Label - Germany
50 microgram/hour Carton Label - Sweden
50 microgram/hour Carton Label - Czech
50 microgram/hour Carton Label - Greece
50 microgram/hour Carton Label - Denmark
50 microgram/hour Carton Label - Netherlands
50 microgram/hour Carton Label - France
50 microgram/hour Carton Label - Portugal
50 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 75 microgram/hour

75 microgram/hour Carton Label - UK
75 microgram/hour Carton Label - Belgium
75 microgram/hour Carton Label - Germany
75 microgram/hour Carton Label - Sweden
75 microgram/hour Carton Label - Czech
75 microgram/hour Carton Label - Greece
75 microgram/hour Carton Label - Denmark
75 microgram/hour Carton Label - Netherlands
75 microgram/hour Carton Label - France
75 microgram/hour Carton Label - Portugal
75 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 100 microgram/hour

100 microgram/hour Carton Label - UK
100 microgram/hour Carton Label - Belgium
100 microgram/hour Carton Label - Germany
100 microgram/hour Carton Label - Sweden
100 microgram/hour Carton Label - Czech
100 microgram/hour Carton Label - Greece
100 microgram/hour Carton Label - Denmark
100 microgram/hour Carton Label - Netherlands
100 microgram/hour Carton Label - France
100 microgram/hour Carton Label - Portugal
100 microgram/hour Carton Label - Spain
FENTANYL 
fentanyl patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59490-4190
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL12 ug  in 1 h
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59490-4190-95 in 1 CARTON01/01/2019
11 in 1 POUCH
172 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2019
FENTANYL 
fentanyl patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59490-4191
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL25 ug  in 1 h
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59490-4191-95 in 1 CARTON01/01/2019
11 in 1 POUCH
172 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2019
FENTANYL 
fentanyl patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59490-4192
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL50 ug  in 1 h
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59490-4192-95 in 1 CARTON01/01/2019
11 in 1 POUCH
172 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2019
FENTANYL 
fentanyl patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59490-4193
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL75 ug  in 1 h
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59490-4193-95 in 1 CARTON01/01/2019
11 in 1 POUCH
172 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2019
FENTANYL 
fentanyl patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59490-4194
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL100 ug  in 1 h
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59490-4194-95 in 1 CARTON01/01/2019
11 in 1 POUCH
172 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2019
Labeler - Mylan Technologies Inc. (063790265)

Revised: 1/2019
Document Id: f5256dd5-2c66-42dd-a423-a9cd5eb24d14
Set id: eec9848f-56b0-428c-becd-4f9c7100faed
Version: 3
Effective Time: 20190122
 
Mylan Technologies Inc.