NDC 55700-597

Fentanyl System

Fentanyl

Fentanyl System is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Fentanyl.

Product ID55700-597_0be26ea2-6947-47b9-8eb0-96b2426607e6
NDC55700-597
Product TypeHuman Prescription Drug
Proprietary NameFentanyl System
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2018-04-13
Marketing CategoryANDA / ANDA
Application NumberANDA202097
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameFENTANYL
Active Ingredient Strength25 ug/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55700-597-05

1 POUCH in 1 CARTON (55700-597-05) > 5 PATCH in 1 POUCH
Marketing Start Date2018-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-597-05 [55700059705]

Fentanyl System PATCH
Marketing CategoryANDA
Application NumberANDA202097
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-13
Marketing End Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
FENTANYL25 ug/1

OpenFDA Data

SPL SET ID:ff9536e1-a4e8-4eb3-901c-ba9b86256672
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245134

    • Pharmacological Class

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

    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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