NDC 0409-4755

Ondansetron

Ondansetron

Ondansetron is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Ondansetron Hydrochloride.

Product ID0409-4755_5f4bb8cb-7712-4d9e-afbd-4957bf2138b1
NDC0409-4755
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2008-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA077548
Labeler NameHospira, Inc.
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 0409-4755-03

25 VIAL, SINGLE-DOSE in 1 CARTON (0409-4755-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-4755-18)
Marketing Start Date2008-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-4755-01 [00409475501]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-11-02
Marketing End Date2009-04-01

NDC 0409-4755-12 [00409475512]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-24
Marketing End Date2017-10-16

NDC 0409-4755-03 [00409475503]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-10-16

NDC 0409-4755-02 [00409475502]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-29
Marketing End Date2010-08-01

NDC 0409-4755-18 [00409475518]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-24

NDC 0409-4755-11 [00409475511]

Ondansetron INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-24
Marketing End Date2017-10-16

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:6a11f61b-2318-4382-2b91-4366e4bb53fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283504
  • 1740467

    • Pharmacological Class

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

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

    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
    0409-1120OndansetronONDANSETRON
    0409-4755OndansetronONDANSETRON
    0409-4759OndansetronONDANSETRON
    0641-6078OndansetronOndansetron
    0641-6079OndansetronOndansetron
    0641-6080OndansetronOndansetron
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    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
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