Fentanyl
Approved
Approval ID
b7fe401c-7ddc-4391-9cff-3608da03e86b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 5
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 Code54868-0162
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (2)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENTANYLActive
Quantity: 2.55 mg in 1 [USP'U]
Code: UF599785JZ
Classification: ACTIB
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0287
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (2)
FENTANYLActive
Quantity: 7.65 mg in 1 [USP'U]
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5963
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (2)
FENTANYLActive
Quantity: 1.28 mg in 1 [USP'U]
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0244
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (2)
FENTANYLActive
Quantity: 5.10 mg in 1 [USP'U]
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1523
Application NumberANDA076258
Product Classification
M
Marketing Category
C73584
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 17, 2010
FDA Product Classification
INGREDIENTS (2)
FENTANYLActive
Quantity: 10.20 mg in 1 [USP'U]
Code: UF599785JZ
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT