NDC 69543-371

Palonosetron hydrochloride

Palonosetron Hydrochloride

Palonosetron hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals, Llc. The primary component is Palonosetron Hydrochloride.

Product ID69543-371_69323708-48a3-4f29-8e92-2c6e010093fe
NDC69543-371
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron hydrochloride
Generic NamePalonosetron Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA209287
Labeler NameVirtus Pharmaceuticals, LLC
Substance NamePALONOSETRON HYDROCHLORIDE
Active Ingredient Strength0 mg/5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69543-371-10

10 CARTON in 1 BOX (69543-371-10) > 1 VIAL in 1 CARTON (69543-371-01) > 5 mL in 1 VIAL
Marketing Start Date2018-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69543-371-01 [69543037101]

Palonosetron hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209287
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-19

NDC 69543-371-10 [69543037110]

Palonosetron hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209287
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-19

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

OpenFDA Data

SPL SET ID:ba2ece34-a3da-420d-a79c-4e53d11af5f3
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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