NDC 52959-658

Fentanyl

Fentanyl

Fentanyl is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Fentanyl.

Product ID52959-658_724f7d0e-6859-4bb9-abd5-8d3cd456475a
NDC52959-658
Product TypeHuman Prescription Drug
Proprietary NameFentanyl
Generic NameFentanyl
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2010-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA077775
Labeler NameH.J. Harkins Company, Inc.
Substance NameFENTANYL
Active Ingredient Strength100 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-658-05

5 POUCH in 1 CARTON (52959-658-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-658-05 [52959065805]

Fentanyl PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077775
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
FENTANYL100 ug/h

OpenFDA Data

SPL SET ID:955cae30-8bfb-46a5-9878-bbc9578493d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68258-3023FentanylFentanyl
    68258-3040FentanylFentanyl
    68258-3024FentanylFentanyl
    68258-3025FentanylFentanyl
    71335-0376FENTANYLFENTANYL
    71335-0649FentanylFentanyl
    71335-0556FentanylFentanyl
    71335-0604FentanylFentanyl
    35356-633FENTANYLFENTANYL
    35356-635FentanylFentanyl
    35356-062FentanylFentanyl
    35356-632FENTANYLFENTANYL
    35356-634FENTANYLFENTANYL
    49884-763FentanylFentanyl
    49884-762FentanylFentanyl
    49884-764FentanylFentanyl
    49884-761FentanylFentanyl
    49999-834FentanylFentanyl
    49999-832FentanylFentanyl
    49999-833FentanylFentanyl
    49999-831FentanylFentanyl
    51862-317FentanylFentanyl
    51862-314FentanylFentanyl
    51862-316FentanylFentanyl
    51862-315FentanylFentanyl
    52959-585FentanylFentanyl
    52959-658FentanylFentanyl
    55700-402FENTANYLFENTANYL
    60505-7081FENTANYLFENTANYL
    60505-7086FENTANYLFENTANYL
    60505-7082FENTANYLFENTANYL
    60505-7009FENTANYLFENTANYL
    60505-7014FENTANYLFENTANYL

    Trademark Results [Fentanyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FENTANYL
    FENTANYL
    98644202 not registered Live/Pending
    Ghost Global LLC
    2024-07-11
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