NDC 49999-834

Fentanyl

Fentanyl

Fentanyl is a Transdermal Patch, Extended Release 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 ID49999-834_f9fc2d3e-3f70-459a-8a22-588bd6dd2443
NDC49999-834
Product TypeHuman Prescription Drug
Proprietary NameFentanyl
Generic NameFentanyl
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2011-12-09
Marketing CategoryANDA / ANDA
Application NumberANDA076709
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameFENTANYL
Active Ingredient Strength100 ug/72h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49999-834-05

5 POUCH in 1 CARTON (49999-834-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Marketing Start Date2011-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-834-05 [49999083405]

Fentanyl PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076709
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-09
Marketing End Date2014-12-31

Drug Details

Active Ingredients

IngredientStrength
FENTANYL100 ug/72h

OpenFDA Data

SPL SET ID:491dd1b2-b91a-4bd9-b022-159b8717699e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245136
  • 245135
  • 245134
  • 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

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