NDC 63629-5492

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 Bryant Ranch Prepack. The primary component is Fentanyl.

Product ID63629-5492_5fd288e9-8f19-474c-a00f-3a86d2ce5358
NDC63629-5492
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 NameBryant Ranch Prepack
Substance NameFENTANYL
Active Ingredient Strength50 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-5492-1

5 h in 1 BOTTLE (63629-5492-1)
Marketing Start Date2014-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5492-1 [63629549201]

FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL50 ug/h

OpenFDA Data

SPL SET ID:9393d796-fb80-4d65-8624-04aa1b82080d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
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