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 for transdermal administration, CIIInitial U.S. Approval: 1968
Approved
Approval ID
ff9536e1-a4e8-4eb3-901c-ba9b86256672
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2022
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
Products 1
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 Code55700-597
Application NumberANDA202097
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (2)
FentanylActive
Quantity: 25 ug in 1 1
Code: UF599785JZ
Classification: ACTIB
Methyl LaurateInactive
Code: 8IPS6BI6KW
Classification: IACT