NDC 35356-556

buprenorphine hydrochloride

Buprenorphine Hydrochloride

buprenorphine hydrochloride is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Buprenorphine Hydrochloride.

Product ID35356-556_c8c73f4a-6e3f-425c-8806-0ed1c9c2e59a
NDC35356-556
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 NameLake Erie Medical DBA Quality Care Products 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 35356-556-30

30 TABLET in 1 BOTTLE (35356-556-30)
Marketing Start Date2011-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-556-30 [35356055630]

buprenorphine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090622
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-11
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:56253ae5-e4d9-481b-817f-b5e18094772c
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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