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, CII Initial U.S. Approval: 1968
Approved
Approval ID
0ff70df0-2cda-d96c-42a8-3bf180310498
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 10
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 Code60505-7015
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
FENTANYLActive
Quantity: 37.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7007
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
FENTANYLActive
Quantity: 50 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7011
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
FENTANYLActive
Quantity: 25 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7006
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYLActive
Quantity: 25 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7013
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYLActive
Quantity: 75 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7016
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYLActive
Quantity: 62.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7008
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYLActive
Quantity: 75 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7009
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
FENTANYLActive
Quantity: 100 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7010
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYLActive
Quantity: 12 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
FENTANYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-7017
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENTANYL
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYLActive
Quantity: 87.5 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 10/31/2018
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 1/2018
Boxed Warning 09/2018
Warnings and Precautions ( 5.2) 09/2019
Key Highlight
Dosage and Administration ( 2) 1/2018
Boxed Warning 09/2018
Warnings and Precautions ( 5.2) 09/2019