NDC 50458-104

DURAGESIC (fentanyl system)

Fentanyl

DURAGESIC (fentanyl system) is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Fentanyl.

Product ID50458-104_05923670-9dd6-4a7c-91b6-1483b3db3c29
NDC50458-104
Product TypeHuman Prescription Drug
Proprietary NameDURAGESIC (fentanyl system)
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2018-11-05
Marketing CategoryNDA / NDA
Application NumberNDA019813
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameFENTANYL
Active Ingredient Strength50 ug/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50458-104-05

5 POUCH in 1 BOX (50458-104-05) > 1 PATCH in 1 POUCH
Marketing Start Date2018-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-104-05 [50458010405]

DURAGESIC (fentanyl system) PATCH
Marketing CategoryNDA
Application NumberNDA019813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-15

Drug Details

Active Ingredients

IngredientStrength
FENTANYL50 ug/1

OpenFDA Data

SPL SET ID:4c3a6171-19e4-40c2-83f3-fb54d4736e4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261184
  • 261185
  • 197696
  • 583490
  • 245136
  • 245135
  • 245134
  • 577057
  • 262071
  • 261186
  • Pharmacological Class

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

    NDC Crossover Matching brand name "DURAGESIC (fentanyl system)" or generic name "Fentanyl"

    NDCBrand NameGeneric Name
    50458-101DURAGESIC (fentanyl system)DURAGESIC (fentanyl system)
    50458-106DURAGESIC (fentanyl system)DURAGESIC (fentanyl system)
    50458-102DURAGESIC (fentanyl system)DURAGESIC (fentanyl system)
    50458-104DURAGESIC (fentanyl system)DURAGESIC (fentanyl system)
    50458-105DURAGESIC (fentanyl system)DURAGESIC (fentanyl system)
    0378-9119FENTANYLFENTANYL
    0378-9121FENTANYLFENTANYL
    0378-9122FENTANYLFENTANYL
    0378-9123FENTANYLFENTANYL
    0378-9124FENTANYLFENTANYL
    0378-9125FENTANYLFENTANYL
    0378-9126FENTANYLFENTANYL
    0378-9127FENTANYLFENTANYL
    0591-3198FentanylFentanyl
    0591-3212FentanylFentanyl
    0591-3213FentanylFentanyl
    0591-3214FentanylFentanyl
    0781-7240FentanylFentanyl
    0781-7241FentanylFentanyl
    0781-7242FentanylFentanyl
    0781-7243FentanylFentanyl
    0781-7244FentanylFentanyl
    20482-001SUBSYSfentanyl
    20482-002SUBSYSfentanyl

    Trademark Results [DURAGESIC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DURAGESIC
    DURAGESIC
    74042858 1684794 Live/Registered
    JOHNSON & JOHNSON
    1990-03-23
    DURAGESIC
    DURAGESIC
    72212690 0808358 Dead/Expired
    MEYER LABORATORIES, INC.
    1965-02-24

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.