NDC 60505-6193

Palonosetron

Palonosetron Hydrochloride

Palonosetron is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Palonosetron Hydrochloride.

Product ID60505-6193_2ec3f905-2fe9-44e6-bce9-57b72ba5009a
NDC60505-6193
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron
Generic NamePalonosetron Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA205648
Labeler NameApotex Corp.
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 60505-6193-1

1 VIAL in 1 CARTON (60505-6193-1) > 5 mL in 1 VIAL
Marketing Start Date2018-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6193-1 [60505619301]

Palonosetron INJECTION
Marketing CategoryANDA
Application NumberANDA205648
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:903d7aba-277e-6d28-4fee-fd2d605ab6a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728055
  • UPC Code
  • 0360505619313
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    16714-834PalonosetronPalonosetron
    55111-694PalonosetronPalonosetron
    60505-6193PalonosetronPalonosetron Hydrochloride
    68001-355PalonosetronPalonosetron
    63323-673PalonosetronPalonosetron
    63323-942PalonosetronPalonosetron
    67184-0514PalonosetronPalonosetron
    67184-0515PalonosetronPalonosetron
    68001-482PalonosetronPalonosetron
    62856-797Aloxipalonosetron hydrochloride
    62856-798Aloxipalonosetron 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

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