NDC 65293-373

Ondansetron

Ondansetron Hydrochloride

Ondansetron is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Ondansetron Hydrochloride.

Product ID65293-373_99d569d6-8690-560b-e053-2a95a90a0780
NDC65293-373
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 NameThe Medicines Company
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65293-373-25

25 VIAL in 1 TRAY (65293-373-25) > 2 mL in 1 VIAL (65293-373-02)
Marketing Start Date2009-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65293-373-25 [65293037325]

Ondansetron INJECTION
Marketing CategoryANDA
Application NumberANDA076972
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-17
Marketing End Date2015-01-31

NDC 65293-373-02 [65293037302]

Ondansetron INJECTION
Marketing CategoryANDA
Application NumberANDA076972
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-11-18
Marketing End Date2015-01-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:dc3dc0e4-b7da-4da4-afa6-d57e4ee42339
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283504
  • 1740467
    • UPC Code
  • 0365293373256

    • Pharmacological Class

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

    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
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