NDC 76045-103

ONDANSETRON

Ondansetron Hydrochloride

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

Product ID76045-103_9b02521d-f246-1860-e053-2995a90a5399
NDC76045-103
Product TypeHuman Prescription Drug
Proprietary NameONDANSETRON
Generic NameOndansetron Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2015-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA202253
Labeler NameFresenius Kabi USA, LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/2mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76045-103-20

24 BLISTER PACK in 1 CARTON (76045-103-20) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 2 mL in 1 SYRINGE, GLASS
Marketing Start Date2015-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76045-103-20 [76045010320]

ONDANSETRON INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA202253
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-10

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/2mL

OpenFDA Data

SPL SET ID:d89017aa-b8c3-4fd2-8e68-44e2cfd6f290
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1314133
  • 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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