NDC 63629-5073

Ondansetron

Ondansetron

Ondansetron is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ondansetron Hydrochloride.

Product ID63629-5073_afecd5ca-20fc-45b9-ab29-98aeaffaf572
NDC63629-5073
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077535
Labeler NameBryant Ranch Prepack
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-5073-2

10 TABLET, FILM COATED in 1 BOTTLE (63629-5073-2)
Marketing Start Date2007-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5073-3 [63629507303]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-26
Marketing End Date2017-12-31

NDC 63629-5073-1 [63629507301]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-26
Marketing End Date2017-12-31

NDC 63629-5073-2 [63629507302]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-26
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:9de27267-5b84-45e1-afb9-26022e075263
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198052

    • 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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