NDC 62756-460

Buprenorphine

Buprenorphine

Buprenorphine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID62756-460_08390835-7842-4d31-aef0-914124b1a117
NDC62756-460
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2016-02-17
Marketing CategoryANDA / ANDA
Application NumberANDA201760
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 62756-460-64

3 BLISTER PACK in 1 CARTON (62756-460-64) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2016-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-460-64 [62756046064]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA201760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-17

NDC 62756-460-83 [62756046083]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA201760
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-17

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:9fd1f18f-0b0f-4059-b603-19ecbf0ed63a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 351264
    • UPC Code
  • 0362756460836

    • Pharmacological Class

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

    Medicade Reported Pricing

    62756046083 BUPRENORPHINE 8 MG TABLET SL

    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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