NDC 12496-0100

SUBLOCADE

Buprenorphine

SUBLOCADE is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is Buprenorphine.

Product ID12496-0100_07dfc3a0-d6b1-4ca4-939a-2fb001a52164
NDC12496-0100
Product TypeHuman Prescription Drug
Proprietary NameSUBLOCADE
Generic NameBuprenorphine
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-02-26
Marketing CategoryNDA / NDA
Application NumberNDA209819
Labeler NameIndivior Inc.
Substance NameBUPRENORPHINE
Active Ingredient Strength100 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12496-0100-1

1 POUCH in 1 CARTON (12496-0100-1) > 1 SYRINGE in 1 POUCH (12496-0100-2) > 1 SOLUTION in 1 SYRINGE (12496-0100-5)
Marketing Start Date2018-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12496-0100-2 [12496010002]

SUBLOCADE SOLUTION
Marketing CategoryNDA
Application NumberNDA209819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-26

NDC 12496-0100-5 [12496010005]

SUBLOCADE SOLUTION
Marketing CategoryNDA
Application NumberNDA209819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-26

NDC 12496-0100-1 [12496010001]

SUBLOCADE SOLUTION
Marketing CategoryNDA
Application NumberNDA209819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-26

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE100 mg/1

OpenFDA Data

SPL SET ID:6189fb21-9432-45f8-8481-0bfaf3ccde95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1996184
  • 1996192
  • 1996189
  • 1996193
  • Pharmacological Class

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

    NDC Crossover Matching brand name "SUBLOCADE" or generic name "Buprenorphine"

    NDCBrand NameGeneric Name
    12496-0300SUBLOCADESUBLOCADE
    12496-0100SUBLOCADESUBLOCADE
    0093-3239BuprenorphineBuprenorphine
    0093-3600BuprenorphineBuprenorphine
    0093-3601BuprenorphineBuprenorphine
    0093-3602BuprenorphineBuprenorphine
    0093-3603BuprenorphineBuprenorphine
    0093-3656BuprenorphineBuprenorphine
    0093-3657BuprenorphineBuprenorphine
    0093-3658BuprenorphineBuprenorphine
    0093-3659BuprenorphineBuprenorphine
    0228-3153BuprenorphineBuprenorphine
    0228-3156BuprenorphineBuprenorphine

    Trademark Results [SUBLOCADE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUBLOCADE
    SUBLOCADE
    87329052 5587023 Live/Registered
    Indivior UK Limited
    2017-02-08
    SUBLOCADE
    SUBLOCADE
    87328982 5587022 Live/Registered
    Indivior UK Limited
    2017-02-08
    SUBLOCADE
    SUBLOCADE
    87210504 5880436 Live/Registered
    Indivior UK Limited
    2016-10-20
    SUBLOCADE
    SUBLOCADE
    87210480 5586819 Live/Registered
    Indivior UK Limited
    2016-10-20

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