NDC 58284-100

Probuphine

Buprenorphine Hydrochloride

Probuphine is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Braeburn Pharmaceuticals. The primary component is Buprenorphine Hydrochloride.

Product ID58284-100_344bc806-d9ba-4249-9ed8-390a2822e9d5
NDC58284-100
Product TypeHuman Prescription Drug
Proprietary NameProbuphine
Generic NameBuprenorphine Hydrochloride
Dosage FormImplant
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-06-09
Marketing CategoryNDA / NDA
Application NumberNDA204442
Labeler NameBraeburn Pharmaceuticals
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58284-100-14

4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH
Marketing Start Date2016-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58284-100-14 [58284010014]

Probuphine IMPLANT
Marketing CategoryNDA
Application NumberNDA204442
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-09
Marketing End Date2019-04-02

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:10fd7088-cc4a-4bda-a5e3-a82563540a9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797650
  • 1797655

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    52440-100Probuphinebuprenorphine hydrochloride
    58284-100ProbuphineProbuphine
    55700-867BELBUCAbuprenorphine hydrochloride
    12496-0757Buprenexbuprenorphine 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

    Trademark Results [Probuphine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROBUPHINE
    PROBUPHINE
    86356901 5171923 Live/Registered
    Titan Pharmaceuticals, Inc.
    2014-08-04
    PROBUPHINE
    PROBUPHINE
    85867659 5166633 Live/Registered
    Titan Pharmaceuticals, Inc.
    2013-03-05
    PROBUPHINE
    PROBUPHINE
    85110551 4102980 Live/Registered
    Titan Pharmaceuticals, Inc.
    2010-08-18
    PROBUPHINE
    PROBUPHINE
    76281064 2800862 Dead/Cancelled
    Titan Pharmaceuticals, Inc.
    2001-07-06
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