NDC 71335-0353

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 ID71335-0353_2369cc02-12e9-45f7-bc13-78fa7e0c7c5c
NDC71335-0353
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2015-02-19
Marketing CategoryANDA / ANDA
Application NumberANDA090819
Labeler NameBryant Ranch Prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0353-1

60 TABLET in 1 BOTTLE (71335-0353-1)
Marketing Start Date2022-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0353-4 [71335035304]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-2 [71335035302]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-1 [71335035301]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-5 [71335035305]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-7 [71335035307]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-3 [71335035303]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

NDC 71335-0353-6 [71335035306]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA090819
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-26

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:691abbd4-0af9-44b5-a510-efe2722d00be
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.