NDC 12496-0757

Buprenex

Buprenorphine Hydrochloride

Buprenex is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Reckitt Benckiser Pharmaceuticals Inc. The primary component is Buprenorphine Hydrochloride.

Product ID12496-0757_3ab3d736-0ea2-4f76-8325-fa3ad227dbc5
NDC12496-0757
Product TypeHuman Prescription Drug
Proprietary NameBuprenex
Generic NameBuprenorphine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1985-06-30
Marketing CategoryNDA / NDA
Application NumberNDA018401
Labeler NameReckitt Benckiser Pharmaceuticals 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 Through2019-12-31

Packaging

NDC 12496-0757-5

5 AMPULE in 1 CARTON (12496-0757-5) > 1 mL in 1 AMPULE (12496-0757-1)
Marketing Start Date1985-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12496-0757-5 [12496075705]

Buprenex INJECTION
Marketing CategoryNDA
Application NumberNDA018401
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-06-30

NDC 12496-0757-1 [12496075701]

Buprenex INJECTION
Marketing CategoryNDA
Application NumberNDA018401
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-06-30

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.3 mg/mL

OpenFDA Data

SPL SET ID:b086772e-d15a-4d13-b1a2-38bfbde1f18c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205533
  • 238129

    • Pharmacological Class

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

    Medicade Reported Pricing

    12496075701 BUPRENEX 0.3 MG/ML AMPUL

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    12496-0757Buprenexbuprenorphine hydrochloride
    55700-867BELBUCAbuprenorphine hydrochloride
    50090-2924BuprenorphineBuprenorphine Hydrochloride
    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
    52440-100Probuphinebuprenorphine hydrochloride

    Trademark Results [Buprenex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BUPRENEX
    BUPRENEX
    73250235 1229185 Live/Registered
    Reckitt & Colman (Overseas) Limited
    1980-02-14
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