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Fentanyl system

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

242759ef-cb6d-4e3e-9f8d-5e31efa1f289

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2024

Manufacturers
FDA

ALVOGEN

DUNS: 008057330

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 Code47781-427
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

METHYL LAURATEInactive
Code: 8IPS6BI6KW
Classification: IACT
FENTANYLActive
Quantity: 75 ug in 1 1
Code: UF599785JZ
Classification: ACTIB

Fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47781-428
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

METHYL LAURATEInactive
Code: 8IPS6BI6KW
Classification: IACT
FENTANYLActive
Quantity: 100 ug in 1 1
Code: UF599785JZ
Classification: ACTIB

Fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47781-424
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

FENTANYLActive
Quantity: 25 ug in 1 1
Code: UF599785JZ
Classification: ACTIB
METHYL LAURATEInactive
Code: 8IPS6BI6KW
Classification: IACT

Fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47781-423
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

METHYL LAURATEInactive
Code: 8IPS6BI6KW
Classification: IACT
FENTANYLActive
Quantity: 12.5 ug in 1 1
Code: UF599785JZ
Classification: ACTIB

Fentanyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47781-426
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 18, 2024
FDA Product Classification

INGREDIENTS (2)

METHYL LAURATEInactive
Code: 8IPS6BI6KW
Classification: IACT
FENTANYLActive
Quantity: 50 ug in 1 1
Code: UF599785JZ
Classification: ACTIB

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