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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

3bbc19e3-5bf1-495a-b698-3d77f83236e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2023

Manufacturers
FDA

Quality Care Products, LLC

DUNS: 831276758

Products 4

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 Code55700-753
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: 25 ug in 1 h
Code: UF599785JZ
Classification: ACTIB

FENTANYL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55700-749
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)

POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYLActive
Quantity: 12 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT

FENTANYL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55700-748
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)

OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
FENTANYLActive
Quantity: 50 ug in 1 h
Code: UF599785JZ
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7
Classification: IACT

FENTANYL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55700-772
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
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
FENTANYLActive
Quantity: 75 ug in 1 h
Code: UF599785JZ
Classification: ACTIB

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