NDC 0591-3198

Fentanyl

Fentanyl

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

Product ID0591-3198_89a9c234-ef0a-4c40-8473-3ccd17c9640b
NDC0591-3198
Product TypeHuman Prescription Drug
Proprietary NameFentanyl
Generic NameFentanyl
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2007-08-21
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA076709
Labeler NameActavis Pharma, Inc.
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0591-3198-72

5 POUCH in 1 CARTON (0591-3198-72) > 1 PATCH in 1 POUCH (0591-3198-54) > 72 h in 1 PATCH
Marketing Start Date2007-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3198-54 [00591319854]

Fentanyl PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076709
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-21
Marketing End Date2019-08-31

NDC 0591-3198-72 [00591319872]

Fentanyl PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076709
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-21
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/h

OpenFDA Data

SPL SET ID:a596a740-38f6-434d-a516-4a3766f850bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136
  • 197696
  • 245134
  • 245135

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