NDC 51267-890

Contrave Extended-Release

Naltrexone Hydrochloride And Bupropion Hydrochloride

Contrave Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nalpropion Pharmaceuticals Llc. The primary component is Naltrexone Hydrochloride; Bupropion Hydrochloride.

Product ID51267-890_74062009-01b3-4270-9080-139e0f0e29c9
NDC51267-890
Product TypeHuman Prescription Drug
Proprietary NameContrave Extended-Release
Generic NameNaltrexone Hydrochloride And Bupropion Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-10-22
Marketing CategoryNDA / NDA
Application NumberNDA200063
Labeler NameNalpropion Pharmaceuticals LLC
Substance NameNALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51267-890-99

120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)
Marketing Start Date2014-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51267-890-00 [51267089000]

Contrave Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200063
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-10
Marketing End Date2017-05-17

NDC 51267-890-99 [51267089099]

Contrave Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-22

Drug Details

Active Ingredients

IngredientStrength
NALTREXONE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:485ff360-32c8-11df-928b-0002a5d5c51b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1551468
  • 1551474
  • UPC Code
  • 0351267890997
  • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]
    • Aminoketone [EPC]
    • Dopamine Uptake Inhibitors [MoA]
    • Increased Dopamine Activity [PE]
    • Increased Norepinephrine Activity [PE]
    • Norepinephrine Uptake Inhibitors [MoA]

    Medicade Reported Pricing

    51267089099 CONTRAVE ER 8-90 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Contrave Extended-Release" or generic name "Naltrexone Hydrochloride And Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    43063-772Contravenaltrexone hydrochloride and bupropion hydrochloride
    50090-2868CONTRAVEnaltrexone hydrochloride and bupropion hydrochloride
    50090-2945Contravenaltrexone hydrochloride and bupropion hydrochloride
    51267-890Contravenaltrexone hydrochloride and bupropion hydrochloride
    64764-890CONTRAVEnaltrexone hydrochloride and bupropion hydrochloride

    Trademark Results [Contrave]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CONTRAVE
    CONTRAVE
    86026234 5181874 Live/Registered
    Orexigen Therapeutics, Inc.
    2013-08-01
    CONTRAVE
    CONTRAVE
    78979619 3393576 Live/Registered
    NALPROPION PHARMACEUTICALS LLC
    2006-01-06
    CONTRAVE
    CONTRAVE
    78794374 not registered Dead/Abandoned
    AGrow Tech LLC
    2006-01-18
    CONTRAVE
    CONTRAVE
    78786858 not registered Dead/Abandoned
    Orexigen Therapeutics, Inc.
    2006-01-06
    CONTRAVE
    CONTRAVE
    77926232 not registered Dead/Abandoned
    Orexigen Therapeutics, Inc.
    2010-02-02
    CONTRAVE
    CONTRAVE
    77925784 not registered Dead/Abandoned
    Orexigen Therapeutics, Inc.
    2010-02-02
    CONTRAVE
    CONTRAVE
    77811077 not registered Dead/Abandoned
    Orexigen Therapeutics, Inc.
    2009-08-24

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.