NDC 0406-9037

FENTANYL TRANSDERMAL

Fentanyl Transdermal

FENTANYL TRANSDERMAL is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Fentanyl.

Product ID0406-9037_296f98e3-6593-472b-9466-b88d38819303
NDC0406-9037
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL TRANSDERMAL
Generic NameFentanyl Transdermal
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2020-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA077154
Labeler NameSpecGx LLC
Substance NameFENTANYL
Active Ingredient Strength38 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0406-9037-76

5 POUCH in 1 CARTON (0406-9037-76) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date2020-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-9037-76 [00406903776]

FENTANYL TRANSDERMAL PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
FENTANYL37.5 ug/h

OpenFDA Data

SPL SET ID:e15a7e9b-8025-49dd-9a6d-bafcccf1959f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197696
  • 245136
  • 245135
  • 245134
  • 1603498
  • 577057
  • 1603495

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0406-9000FENTANYL TRANSDERMALfentanyl transdermal
    0406-9012FENTANYL TRANSDERMALfentanyl transdermal
    0406-9025FENTANYL TRANSDERMALfentanyl transdermal
    0406-9037FENTANYL TRANSDERMALfentanyl transdermal
    0406-9050FENTANYL TRANSDERMALfentanyl transdermal
    0406-9062FENTANYL TRANSDERMALfentanyl transdermal
    0406-9075FENTANYL TRANSDERMALfentanyl transdermal
    0406-9100FENTANYL TRANSDERMALfentanyl transdermal
    0406-9112FENTANYL TRANSDERMALfentanyl transdermal
    0406-9125FENTANYL TRANSDERMALfentanyl transdermal
    0406-9150FENTANYL TRANSDERMALfentanyl transdermal
    0406-9175FENTANYL TRANSDERMALfentanyl transdermal
    63629-4764FENTANYL TRANSDERMALfentanyl transdermal
    63629-4771FENTANYL TRANSDERMALfentanyl transdermal
    63629-4773FENTANYL TRANSDERMALfentanyl transdermal
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