NDC 71205-109

Ondansetron

Ondansetron Hydrochloride

Ondansetron is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Ondansetron Hydrochloride.

Product ID71205-109_63d86935-3f90-46d6-b2a8-9364e19bee65
NDC71205-109
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-01-27
Marketing CategoryANDA / ANDA
Application NumberANDA091342
Labeler NameProficient Rx LP
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71205-109-50

50 mL in 1 BOTTLE, PLASTIC (71205-109-50)
Marketing Start Date2018-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-109-50 [71205010950]

Ondansetron SOLUTION
Marketing CategoryANDA
Application NumberANDA091342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-04

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

OpenFDA Data

SPL SET ID:c2ae1141-4b73-469f-a14b-f1a52628c2d2
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 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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