NDC 25021-783

palonosetron hydrochloride

Palonosetron Hydrochloride

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

Product ID25021-783_2a972ba4-d27c-4787-bfd3-48f0fcbb64a9
NDC25021-783
Product TypeHuman Prescription Drug
Proprietary Namepalonosetron hydrochloride
Generic NamePalonosetron Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA204289
Labeler NameSagent Pharmaceuticals
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 25021-783-05

1 VIAL in 1 CARTON (25021-783-05) > 5 mL in 1 VIAL
Marketing Start Date2018-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-783-05 [25021078305]

palonosetron hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-15

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.05 mg/mL

OpenFDA Data

SPL SET ID:6e60d03d-eae6-4924-a507-e77ea077c1ab
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.