NDC 0409-2012

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID0409-2012_3f59ad84-8359-4e75-854d-0e6d641590f4
NDC0409-2012
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride
Generic NameBuprenorphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-06-14
Marketing CategoryANDA / ANDA
Application NumberANDA074137
Labeler NameHospira, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-2012-32

10 CARTRIDGE in 1 CARTON (0409-2012-32) > 1 mL in 1 CARTRIDGE (0409-2012-03)
Marketing Start Date2005-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2012-32 [00409201232]

Buprenorphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-14

NDC 0409-2012-01 [00409201201]

Buprenorphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-14
Marketing End Date2010-07-19

NDC 0409-2012-03 [00409201203]

Buprenorphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074137
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-02-28

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.3 mg/mL

OpenFDA Data

SPL SET ID:23aa1bb3-cecf-4e62-29bb-48488bb66fc3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1655032

    • 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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