NDC 35356-638

FENTANYL TRANSDERMAL SYSTEM

Fentanyl Transdermal System

FENTANYL TRANSDERMAL SYSTEM is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Fentanyl.

Product ID35356-638_10e47c3d-bf46-4a85-8830-c1c684c81403
NDC35356-638
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL TRANSDERMAL SYSTEM
Generic NameFentanyl Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2011-06-06
Marketing CategoryANDA / ANDA
Application NumberANDA077154
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameFENTANYL
Active Ingredient Strength75 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-638-05

5 POUCH in 1 CARTON (35356-638-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date2011-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-638-05 [35356063805]

FENTANYL PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-06
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
FENTANYL75 ug/h

OpenFDA Data

SPL SET ID:350a421c-4411-482e-8f2a-41b17f1fe7e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136
  • 197696
  • 245134
  • 245135

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "FENTANYL TRANSDERMAL SYSTEM" or generic name "Fentanyl Transdermal System"

    NDCBrand NameGeneric Name
    0406-9000FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    0406-9012FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    0406-9025FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    0406-9050FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    0406-9075FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    21695-975FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    35356-637FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    35356-638FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    42254-002FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    63629-4764FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    63629-4771FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal
    63629-4773FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    63629-5492FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal system
    71335-0683FENTANYL TRANSDERMAL systemfentanyl transdermal system
    © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.