NDC 21695-975

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 Rebel Distributors Corp. The primary component is Fentanyl.

Product ID21695-975_67cb9ea4-5adb-4a3a-9568-266b6f472078
NDC21695-975
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 NameRebel Distributors Corp
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-975-05

5 POUCH in 1 CARTON (21695-975-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date2011-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-975-05 [21695097505]

FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-09
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/h

OpenFDA Data

SPL SET ID:67cb9ea4-5adb-4a3a-9568-266b6f472078
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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