NDC 47781-423

Fentanyl System

Fentanyl

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

Product ID47781-423_19344ad1-a2c3-4562-8db8-8f60fc2a6ef3
NDC47781-423
Product TypeHuman Prescription Drug
Proprietary NameFentanyl System
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2016-11-04
Marketing CategoryANDA / ANDA
Application NumberANDA202097
Labeler NameAlvogen
Substance NameFENTANYL
Active Ingredient Strength13 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 47781-423-47

1 POUCH in 1 CARTON (47781-423-47) > 5 PATCH in 1 POUCH
Marketing Start Date2016-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-423-47 [47781042347]

Fentanyl System PATCH
Marketing CategoryANDA
Application NumberANDA202097
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-04

NDC 47781-423-11 [47781042311]

Fentanyl System PATCH
Marketing CategoryANDA
Application NumberANDA202097
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-04
Marketing End Date2018-12-13

Drug Details

Active Ingredients

IngredientStrength
FENTANYL12.5 ug/1

OpenFDA Data

SPL SET ID:242759ef-cb6d-4e3e-9f8d-5e31efa1f289
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136
  • 197696
  • 245134
  • 245135
  • 577057

    • Pharmacological Class

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

    Medicade Reported Pricing

    47781042347 FENTANYL 12 MCG/HR PATCH

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    47781-423Fentanyl SystemFentanyl System
    47781-426Fentanyl SystemFentanyl System
    47781-424Fentanyl SystemFentanyl System
    47781-428Fentanyl SystemFentanyl System
    47781-427Fentanyl SystemFentanyl System
    55700-597Fentanyl SystemFentanyl 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
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