NDC 63323-373

Ondansetron

Ondansetron Hydrochloride

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

Product ID63323-373_5da13b4e-e84a-4add-83f1-0d67355c5f4c
NDC63323-373
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA076972
Labeler NameFresenius Kabi USA, LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-373-02

25 VIAL in 1 TRAY (63323-373-02) > 2 mL in 1 VIAL (63323-373-00)
Marketing Start Date2009-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-373-00 [63323037300]

Ondansetron INJECTION
Marketing CategoryANDA
Application NumberANDA076972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-12

NDC 63323-373-02 [63323037302]

Ondansetron INJECTION
Marketing CategoryANDA
Application NumberANDA076972
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-11-18

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:e0050959-c14c-41b6-9a92-fadc5f6feff3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283504
  • 1740467
    • UPC Code
  • 0363323374204

    • Pharmacological Class

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

    Medicade Reported Pricing

    63323037302 ONDANSETRON HCL 4 MG/2 ML VIAL

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0143-2422OndansetronOndansetron hydrochloride
    0143-2423OndansetronOndansetron hydrochloride
    0143-2424OndansetronOndansetron
    0143-9890OndansetronOndansetron
    0143-9891OndansetronOndansetron
    0179-0099ondansetronondansetron hydrochloride
    0179-0100ondansetronondansetron hydrochloride
    0378-0315Ondansetronondansetron
    0378-0344Ondansetronondansetron
    0378-0374Ondansetronondansetron
    0378-7732OndansetronOndansetron
    0378-7734OndansetronOndansetron
    0404-9930ONDANSETRONONDANSETRON
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    0409-4755OndansetronOndansetron
    0409-4759OndansetronOndansetron
    68001-247OndansetronOndansetron
    68001-246OndansetronOndansetron
    68071-1547OndansetronOndansetron
    68071-1804OndansetronOndansetron
    68071-1658OndansetronOndansetron
    68071-1730OndansetronOndansetron
    68071-1904OndansetronOndansetron
    68071-1649OndansetronOndansetron
    68071-1987OndansetronOndansetron
    68071-1968ONDANSETRONONDANSETRON
    68071-1977ONDANSETRONONDANSETRON
    68071-3028OndansetronOndansetron
    68071-3195OndansetronOndansetron
    68071-3268OndansetronOndansetron
    68071-4190OndansetronOndansetron
    68071-3275OndansetronOndansetron
    68071-4191ONDANSETRONONDANSETRON
    68071-4513OndansetronOndansetron
    68071-4426OndansetronOndansetron
    68071-4115OndansetronOndansetron
    68071-4566OndansetronOndansetron
    68071-4570OndansetronOndansetron
    68071-4409OndansetronOndansetron
    68071-4594OndansetronOndansetron
    68071-4810OndansetronOndansetron
    68071-4717OndansetronOndansetron
    68083-114OndansetronOndansetron
    68083-113OndansetronOndansetron
    68071-4529ondansetronondansetron
    68258-7068OndansetronOndansetron
    68462-105OndansetronOndansetron
    68462-157OndansetronOndansetron
    68462-158OndansetronOndansetron
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.