Fentanyl
FENTANYL TRANSDERMAL SYSTEM CIIRx only
Approved
Approval ID
0a639bb3-2883-47f7-b117-737df8bed33c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2010
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
Products 3
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 Code68258-3025
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMarch 3, 2010
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 100 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-3024
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMarch 3, 2010
FDA Product Classification
INGREDIENTS (3)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
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 Code68258-3023
Application NumberANDA077449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMarch 3, 2010
FDA Product Classification
INGREDIENTS (3)
FENTANYLActive
Quantity: 25 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT