NDC 67457-317

Palonosetron Hydrochloride

Palonosetron Hydrochloride

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

Product ID67457-317_137d27d9-61b0-48b7-9f71-fe0747a315ee
NDC67457-317
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron Hydrochloride
Generic NamePalonosetron Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-20
Marketing CategoryANDA / ANDA
Application NumberANDA206416
Labeler NameMylan Institutional 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 Through2020-12-31

Packaging

NDC 67457-317-25

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-317-25 [67457031725]

Palonosetron Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-20

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

OpenFDA Data

SPL SET ID:0a781796-bb74-4c5f-8d26-9ce520b818f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728055

    • Pharmacological Class

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