NDC 0781-3415

Palonosetron Hydrochloride

Palonosetron Hydrochloride

Palonosetron Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Palonosetron Hydrochloride.

Product ID0781-3415_5bfb3984-2b47-4e06-9bbb-d055ebc376c8
NDC0781-3415
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron Hydrochloride
Generic NamePalonosetron Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA202521
Labeler NameSandoz Inc
Substance NamePALONOSETRON HYDROCHLORIDE
Active Ingredient Strength0 mg/5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-3415-75

1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

OpenFDA Data

SPL SET ID:5bfb3984-2b47-4e06-9bbb-d055ebc376c8
Manufacturer:Sandoz Inc
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728055
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    62856-797Aloxipalonosetron hydrochloride
    62856-798Aloxipalonosetron hydrochloride
    69639-103Aloxipalonosetron hydrochloride
    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
    25021-783palonosetron hydrochloridepalonosetron hydrochloride
    25021-788palonosetron hydrochloridepalonosetron hydrochloride
    55150-186Palonosetron HydrochloridePalonosetron Hydrochloride
    67457-317Palonosetron HydrochloridePalonosetron Hydrochloride
    69097-439Palonosetron hydrochloridePalonsetron hydrochloride
    69097-927palonosetron hydrochloridepalonosetron hydrochloride
    69543-371Palonosetron hydrochloridePalonosetron hydrochloride

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