NDC 54123-907

Zubsolv

Buprenorphine Hydrochloride And Naloxone Hydrochloride

Zubsolv is a Sublingual Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Orexo Us, Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

Product ID54123-907_568c06d0-5a40-4a95-aff6-08c8af8bb6f9
NDC54123-907
Product TypeHuman Prescription Drug
Proprietary NameZubsolv
Generic NameBuprenorphine Hydrochloride And Naloxone Hydrochloride
Dosage FormTablet, Orally Disintegrating
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-07-04
Marketing CategoryNDA / NDA
Application NumberNDA204242
Labeler NameOrexo US, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54123-907-30

3 BLISTER PACK in 1 CARTON (54123-907-30) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2013-07-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54123-907-30 [54123090730]

Zubsolv TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA204242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-04

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.7 mg/1

OpenFDA Data

SPL SET ID:5f5cfcfe-d52b-49e6-8fe4-550477332dd2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666338
  • 1597570
  • 1597573
  • 1597575
  • 1431076
  • 1597568
  • 1431083
  • 1666385
  • 1864412
  • 1431104
  • 1431102
  • 1864414
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Zubsolv" or generic name "Buprenorphine Hydrochloride And Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    54123-114Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    54123-907Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    54123-914Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    54123-929Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    54123-957Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    54123-986Zubsolvbuprenorphine hydrochloride and naloxone hydrochloride
    50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride
    50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride
    53217-138Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride
    60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride

    Trademark Results [Zubsolv]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZUBSOLV
    ZUBSOLV
    79279822 not registered Live/Pending
    Orexo AB
    2019-11-29
    ZUBSOLV
    ZUBSOLV
    79279802 not registered Live/Pending
    Orexo AB
    2019-11-29
    ZUBSOLV
    ZUBSOLV
    79130980 4549698 Live/Registered
    Orexo AB
    2013-04-15
    ZUBSOLV
    ZUBSOLV
    79111641 4307243 Live/Registered
    Orexo AB
    2012-03-29

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