NDC 63629-4092

Buprenorphine hydrochloride

Buprenorphine Hydrochloride

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

Product ID63629-4092_50924708-d935-4e10-825c-b6d340c81efa
NDC63629-4092
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine hydrochloride
Generic NameBuprenorphine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA020732
Labeler Namebryant ranch prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-4092-2

30 TABLET in 1 BOTTLE (63629-4092-2)
Marketing Start Date2009-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4092-2 [63629409202]

Buprenorphine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA020732
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-30
Inactivation Date2020-01-31

NDC 63629-4092-1 [63629409201]

Buprenorphine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA020732
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:7830fe02-a2ec-48cf-85ce-3e3f6dadab4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine hydrochloride" or generic name "Buprenorphine Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9246Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0409-2012Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0517-0725Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    21695-515Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    35356-556buprenorphine hydrochloridebuprenorphine hydrochloride
    42023-179Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    50090-1571buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-924buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-930buprenorphine hydrochloridebuprenorphine hydrochloride
    53217-246buprenorphine hydrochloridebuprenorphine hydrochloride
    70518-0442buprenorphine hydrochloridebuprenorphine hydrochloride
    63629-4092Buprenorphine hydrochlorideBuprenorphine hydrochloride
    63629-7126buprenorphine hydrochloridebuprenorphine hydrochloride
    64725-1924buprenorphine hydrochloridebuprenorphine hydrochloride
    64725-0930buprenorphine hydrochloridebuprenorphine hydrochloride
    67046-991buprenorphine hydrochloridebuprenorphine hydrochloride
    67046-990buprenorphine hydrochloridebuprenorphine hydrochloride
    70518-2216buprenorphine hydrochloridebuprenorphine hydrochloride
    55700-867BELBUCAbuprenorphine hydrochloride
    12496-0757Buprenexbuprenorphine hydrochloride
    50090-2924BuprenorphineBuprenorphine Hydrochloride
    52440-100Probuphinebuprenorphine hydrochloride
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