NDC 50458-091

DURAGESIC

Fentanyl

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

Product ID50458-091_49c7d73a-7ea6-11e8-89ec-d4969d46d017
NDC50458-091
Product TypeHuman Prescription Drug
Proprietary NameDURAGESIC
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date1990-08-07
Marketing CategoryNDA / NDA
Application NumberNDA019813
Labeler NameJanssen Pharmaceuticals,
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Ago
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50458-091-05

5 POUCH in 1 BOX (50458-091-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date1990-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-091-05 [50458009105]

DURAGESIC PATCH
Marketing CategoryNDA
Application NumberNDA019813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-08-07
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/h

OpenFDA Data

SPL SET ID:d7aade83-9e69-4cd5-8dab-dbf1d7b89bb4
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]

    Medicade Reported Pricing

    50458009105 DURAGESIC 25 MCG/HR PATCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "DURAGESIC" or generic name "Fentanyl"

    NDCBrand NameGeneric Name
    50458-090DURAGESICDURAGESIC
    50458-093DURAGESICDURAGESIC
    50458-094DURAGESICDURAGESIC
    50458-091DURAGESICDURAGESIC
    50458-092DURAGESICDURAGESIC
    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
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