NDC 42858-353

Buprenorphine

Buprenorphine

Buprenorphine is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Buprenorphine.

Product ID42858-353_13935ec5-0a92-40f1-b4dc-ddfb30019b12
NDC42858-353
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-07-03
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021306
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameBUPRENORPHINE
Active Ingredient Strength8 ug/h
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42858-353-40

4 POUCH in 1 CARTON (42858-353-40) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
Marketing Start Date2017-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42858-353-40 [42858035340]

Buprenorphine PATCH
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-05

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE7.5 ug/h

OpenFDA Data

SPL SET ID:2738feae-316e-426f-971c-5f142ac01b60
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904870
  • 904880
  • 1542997
  • 904876
  • 1432969
  • Pharmacological Class

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

    Medicade Reported Pricing

    42858035340 BUPRENORPHINE 7.5 MCG/HR PATCH

    Pricing Unit: EA | Drug Type:

    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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