FENTANYL
These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system CIIInitial U.S. Approval: 1968
Approved
Approval ID
2a2238e9-4b5d-c56d-8663-dd354ff9ae0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9123
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 75 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9127
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 87.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9121
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 25 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9126
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENTANYLActive
Quantity: 62.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9119
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYLActive
Quantity: 12 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9122
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 50 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9124
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 100 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9125
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (3)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENTANYLActive
Quantity: 37.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3H
Classification: IACT