NDC 51862-314

Fentanyl

Fentanyl

Fentanyl is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma. The primary component is Fentanyl.

Product ID51862-314_b3c9d169-abfa-49b7-a7f0-5a7ee4636cec
NDC51862-314
Product TypeHuman Prescription Drug
Proprietary NameFentanyl
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-10-02
Marketing CategoryANDA / ANDA
Application NumberANDA077062
Labeler NameMayne Pharma
Substance NameFENTANYL
Active Ingredient Strength25 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51862-314-78

5 POUCH in 1 CARTON (51862-314-78) > 1 PATCH in 1 POUCH (51862-314-52) > 72 h in 1 PATCH
Marketing Start Date2017-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-314-52 [51862031452]

Fentanyl PATCH
Marketing CategoryANDA
Application NumberANDA077062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-02
Marketing End Date2020-03-10

NDC 51862-314-78 [51862031478]

Fentanyl PATCH
Marketing CategoryANDA
Application NumberANDA077062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-02
Marketing End Date2020-03-10

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/h

OpenFDA Data

SPL SET ID:a10a128f-abdd-489b-8794-8b36a634a5e5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136
  • 197696
  • 245134
  • 245135
  • Pharmacological Class

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

    Medicade Reported Pricing

    51862031478 FENTANYL 25 MCG/HR PATCH

    Pricing Unit: EA | Drug Type:

    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.