NDC 69639-103

Aloxi

Palonosetron Hydrochloride

Aloxi is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Palonosetron Hydrochloride.

Product ID69639-103_795f386e-2b45-5092-e053-2991aa0a5820
NDC69639-103
Product TypeHuman Prescription Drug
Proprietary NameAloxi
Generic NamePalonosetron Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-01
Marketing CategoryNDA / NDA
Application NumberNDA021372
Labeler NameHelsinn Therapeutics (U.S.), Inc.
Substance NamePALONOSETRON HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69639-103-01

1 VIAL in 1 CARTON (69639-103-01) > 5 mL in 1 VIAL
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69639-103-01 [69639010301]

Aloxi INJECTION
Marketing CategoryNDA
Application NumberNDA021372
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-01

NDC 69639-103-05 [69639010305]

Aloxi INJECTION
Marketing CategoryNDA
Application NumberNDA021372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.05 mg/mL

OpenFDA Data

SPL SET ID:795f386e-2b44-5092-e053-2991aa0a5820
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728052
  • 1728050
  • 1728056
  • 1728055
    • UPC Code
  • 0369639103057
  • 0369639103019

    • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Aloxi" or generic name "Palonosetron Hydrochloride"

    NDCBrand NameGeneric Name
    62856-797Aloxipalonosetron hydrochloride
    62856-798Aloxipalonosetron hydrochloride
    69639-103AloxiAloxi
    69639-104ALOXIALOXI
    60505-6193PalonosetronPalonosetron Hydrochloride
    67184-0514PalonosetronPalonosetron Hydrochloride
    67184-0515PalonosetronPalonosetron Hydrochloride
    0143-9513Palonosetron HydrochloridePalonosetron Hydrochloride
    0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDE
    0703-4094Palonosetron HydrochloridePalonosetron Hydrochloride
    0781-3312Palonosetron HydrochloridePalonosetron Hydrochloride
    0781-3415Palonosetron HydrochloridePalonosetron Hydrochloride
    16729-365palonosetron hydrochloridepalonosetron hydrochloride
    23155-356Palonosetron HydrochloridePalonosetron Hydrochloride
    25021-783palonosetron hydrochloridepalonosetron hydrochloride
    25021-788palonosetron hydrochloridepalonosetron hydrochloride
    36000-326Palonosetron Hydrochloridepalonosetron hydrochloride
    50742-485Palonosetron HydrochloridePalonosetron Hydrochloride
    55150-186Palonosetron HydrochloridePalonosetron Hydrochloride
    67457-317Palonosetron HydrochloridePalonosetron Hydrochloride

    Trademark Results [Aloxi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALOXI
    ALOXI
    98017461 not registered Live/Pending
    Ingenus Pharmaceuticals, LLC
    2023-05-29
    ALOXI
    ALOXI
    86911254 5144689 Live/Registered
    Helsinn Healthcare SA
    2016-02-17
    ALOXI
    ALOXI
    86488666 not registered Indifferent
    Helsinn Healthcare SA
    0000-00-00
    ALOXI
    ALOXI
    86488652 4897369 Live/Registered
    Helsinn Healthcare SA
    2014-12-22
    ALOXI
    ALOXI
    76377426 2863255 Live/Registered
    Helsinn Healthcare SA
    2002-03-01
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