NDC 16714-834

Palonosetron

Palonosetron

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

Product ID16714-834_2b084c73-fda1-fc3f-d7b3-da7abb19c55b
NDC16714-834
Product TypeHuman Prescription Drug
Proprietary NamePalonosetron
Generic NamePalonosetron
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA201533
Labeler NameNorthStar Rx LLC
Substance NamePALONOSETRON HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16714-834-01

1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2018-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-834-01 [16714083401]

Palonosetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-29

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.05 mg/mL

OpenFDA Data

SPL SET ID:689c953c-2120-2546-67a4-22bb34ba3330
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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