NDC 53217-246

buprenorphine hydrochloride

Buprenorphine Hydrochloride

buprenorphine hydrochloride is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Buprenorphine Hydrochloride.

Product ID53217-246_a2a640a9-1665-4b82-8564-66e4c69c5171
NDC53217-246
Product TypeHuman Prescription Drug
Proprietary Namebuprenorphine hydrochloride
Generic NameBuprenorphine Hydrochloride
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2010-09-24
Marketing CategoryANDA / ANDA
Application NumberANDA090622
Labeler NameAidarex Pharmaceuticals LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-246-30

30 TABLET in 1 BOTTLE (53217-246-30)
Marketing Start Date2010-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-246-30 [53217024630]

buprenorphine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090622
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:74b52f61-c951-4b0e-bd22-2463cb518234
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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