NDC 67184-0515

Palonosetron

Palonosetron Hydrochloride

Palonosetron is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Qilu Pharmaceutical Co., Ltd.. The primary component is Palonosetron Hydrochloride.

Product ID67184-0515_1df92ae9-dbd5-4a83-8116-8b51bee83323
NDC67184-0515
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 NameQilu Pharmaceutical Co., Ltd.
Substance NamePALONOSETRON HYDROCHLORIDE
Active Ingredient Strength0 mg/1.5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67184-0515-2

5 VIAL in 1 CARTON (67184-0515-2) > 1.5 mL in 1 VIAL (67184-0515-1)
Marketing Start Date2018-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67184-0515-2 [67184051502]

Palonosetron INJECTION
Marketing CategoryANDA
Application NumberANDA205648
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-19

NDC 67184-0515-1 [67184051501]

Palonosetron INJECTION
Marketing CategoryANDA
Application NumberANDA205648
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-19

Drug Details

Active Ingredients

IngredientStrength
PALONOSETRON HYDROCHLORIDE.075 mg/1.5mL

OpenFDA Data

SPL SET ID:633abdc2-a942-4eb2-a0f8-f9f4e727211e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728050
  • 1728055
    • UPC Code
  • 0367184051410

    • 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" 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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