NDC 17856-0691

Ondansetron

Ondansetron

Ondansetron is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Ondansetron Hydrochloride.

Product ID17856-0691_30217494-70d2-44a7-9cc6-4f9801f7f0dc
NDC17856-0691
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2010-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA091483
Labeler NameAtlantic Biologicals Corps
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 17856-0691-1

1.5 mL in 1 SYRINGE (17856-0691-1)
Marketing Start Date2021-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0691-4 [17856069104]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-06

NDC 17856-0691-7 [17856069107]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-15

NDC 17856-0691-6 [17856069106]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-28

NDC 17856-0691-5 [17856069105]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-12-17

NDC 17856-0691-1 [17856069101]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-17

NDC 17856-0691-2 [17856069102]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-15

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

OpenFDA Data

SPL SET ID:e5ab38a2-5921-4320-a313-e0080c078046
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312085

    • 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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