NDC 69097-927

palonosetron hydrochloride

Palonosetron Hydrochloride

palonosetron hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Palonosetron Hydrochloride.

Product ID69097-927_04460041-adec-463b-ba9d-6a12038ab672
NDC69097-927
Product TypeHuman Prescription Drug
Proprietary Namepalonosetron hydrochloride
Generic NamePalonosetron Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-03-23
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021372
Labeler NameCipla USA 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 Through2023-12-31

Packaging

NDC 69097-927-35

1 VIAL in 1 CARTON (69097-927-35) > 5 mL in 1 VIAL
Marketing Start Date2018-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-927-35 [69097092735]

palonosetron hydrochloride INJECTION
Marketing CategoryNDA authorized generic
Application NumberNDA021372
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-23

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

OpenFDA Data

SPL SET ID:37e7ef89-fd77-44e0-9271-ae91f8822603
Manufacturer
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
    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
    69097-927palonosetron hydrochloridepalonosetron hydrochloride
    69097-439Palonosetron hydrochloridePalonosetron hydrochloride
    69543-371Palonosetron hydrochloridePalonosetron hydrochloride
    62856-797Aloxipalonosetron hydrochloride
    62856-798Aloxipalonosetron hydrochloride
    60505-6193PalonosetronPalonosetron Hydrochloride
    67184-0514PalonosetronPalonosetron Hydrochloride
    67184-0515PalonosetronPalonosetron Hydrochloride
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