NDC 63323-942

Palonosetron

Palonosetron

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

Product ID63323-942_61109020-f621-4aba-9578-74f156bfc5f0
NDC63323-942
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron
Generic NamePalonosetron
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-01
Marketing CategoryNDA / NDA
Application NumberNDA208109
Labeler NameFresenius Kabi USA, 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 63323-942-90

10 SYRINGE in 1 CARTON (63323-942-90) > 5 mL in 1 SYRINGE (63323-942-42)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-942-41 [63323094241]

Palonosetron INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-01
Marketing End Date2020-02-29

NDC 63323-942-90 [63323094290]

Palonosetron INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01
Marketing End Date2020-02-29

NDC 63323-942-42 [63323094242]

Palonosetron INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01
Marketing End Date2020-02-29

NDC 63323-942-05 [63323094205]

Palonosetron INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-01
Marketing End Date2020-02-29

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.25 mg/5mL

OpenFDA Data

SPL SET ID:65a657b8-f9d4-4a80-8ce5-d6e58b59b916
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" or generic name "Palonosetron"

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

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