NDC 71335-0683

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 ID71335-0683_0a49e28f-d9da-4eac-970a-cc7cf0f51bcc
NDC71335-0683
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL TRANSDERMAL system
Generic NameFentanyl Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2011-02-09
Marketing CategoryANDA / ANDA
Application NumberANDA077154
Labeler NameBryant Ranch Prepack
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0683-1

1 h in 1 BOTTLE (71335-0683-1)
Marketing Start Date2013-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0683-3 [71335068303]

FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-15
Inactivation Date2020-01-31

NDC 71335-0683-1 [71335068301]

FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-15
Inactivation Date2020-01-31

NDC 71335-0683-2 [71335068302]

FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/h

OpenFDA Data

SPL SET ID:0a49e28f-d9da-4eac-970a-cc7cf0f51bcc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245134

    • 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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