NDC 71335-0950

BUPRENORPHINE

Buprenorphine

BUPRENORPHINE is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Buprenorphine Hydrochloride.

Product ID71335-0950_3063a7e3-f858-4b29-9ff8-237473414f8c
NDC71335-0950
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2017-10-25
Marketing CategoryANDA / ANDA
Application NumberANDA207276
Labeler NameBryant Ranch Prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-0950-1

60 TABLET in 1 BOTTLE (71335-0950-1)
Marketing Start Date2018-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0950-2 [71335095002]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-7 [71335095007]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-5 [71335095005]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-6 [71335095006]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-1 [71335095001]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-4 [71335095004]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

NDC 71335-0950-3 [71335095003]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:a7da638f-f590-4577-bff9-15a91c6e7917
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351264

    • 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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