NDC 0093-3603

Buprenorphine

Buprenorphine

Buprenorphine is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Buprenorphine.

Product ID0093-3603_aa750280-23ed-4d6d-9666-780dab437aab
NDC0093-3603
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-05-30
Marketing End Date2019-07-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021306
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameBUPRENORPHINE
Active Ingredient Strength20 ug/h
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN

Packaging

NDC 0093-3603-40

4 POUCH in 1 CARTON (0093-3603-40) > 1 PATCH in 1 POUCH (0093-3603-21) > 168 h in 1 PATCH
Marketing Start Date2017-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-3603-40 [00093360340]

Buprenorphine PATCH, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-30
Marketing End Date2019-07-31

NDC 0093-3603-21 [00093360321]

Buprenorphine PATCH, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-30
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE20 ug/h

OpenFDA Data

SPL SET ID:e352eced-f0e2-40ca-9ca6-121277d0b9fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904870
  • 904880
  • 904876
  • 1432969

    • 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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