NDC 55700-568

Buprenorphine

Buprenorphine

Buprenorphine 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 Buprenorphine.

Product ID55700-568_671fe384-e9c7-427f-ada9-45f52181788e
NDC55700-568
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-12-15
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021306
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameBUPRENORPHINE
Active Ingredient Strength5 ug/h
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-568-04

4 POUCH in 1 CARTON (55700-568-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
Marketing Start Date2017-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-568-04 [55700056804]

Buprenorphine PATCH, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-15
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE5 ug/h

OpenFDA Data

SPL SET ID:31df13b0-8b71-4394-a89b-5b06730ac552
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904880

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine" or generic name "Buprenorphine"

    NDCBrand NameGeneric Name
    0093-3239BuprenorphineBuprenorphine
    0093-3600BuprenorphineBuprenorphine
    0093-3601BuprenorphineBuprenorphine
    0093-3602BuprenorphineBuprenorphine
    0093-3603BuprenorphineBuprenorphine
    0093-3656BuprenorphineBuprenorphine
    0093-3657BuprenorphineBuprenorphine
    0093-3658BuprenorphineBuprenorphine
    0093-3659BuprenorphineBuprenorphine
    0228-3153BuprenorphineBuprenorphine
    0228-3156BuprenorphineBuprenorphine
    70518-0711BuprenorphineBuprenorphine
    70518-1557BuprenorphineBuprenorphine
    70518-1625BuprenorphineBuprenorphine
    71335-0353BuprenorphineBuprenorphine
    71335-0950BUPRENORPHINEBUPRENORPHINE
    42858-586BuprenorphineBuprenorphine
    42858-750BuprenorphineBuprenorphine
    42858-502BUPRENORPHINEBUPRENORPHINE
    42858-501BUPRENORPHINEBUPRENORPHINE
    42858-353BuprenorphineBuprenorphine
    42858-839BuprenorphineBuprenorphine
    42858-493BuprenorphineBuprenorphine
    50090-2924BuprenorphineBuprenorphine
    55700-579BuprenorphineBuprenorphine
    55700-568BuprenorphineBuprenorphine
    58118-3156BuprenorphineBuprenorphine
    62756-459BuprenorphineBuprenorphine
    62756-460BuprenorphineBuprenorphine
    67046-994BuprenorphineBuprenorphine
    67046-995BuprenorphineBuprenorphine
    71335-1154BUPRENORPHINEBUPRENORPHINE
    70518-2218BUPRENORPHINEBUPRENORPHINE
    70518-2217BUPRENORPHINEBUPRENORPHINE
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