NDC 71335-0815

ondansetron

Ondansetron Hydrochloride

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 ID71335-0815_67a58f6d-263a-44f6-a692-38aa4eebda49
NDC71335-0815
Product TypeHuman Prescription Drug
Proprietary Nameondansetron
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameBryant Ranch Prepack
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0815-0

5 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0)
Marketing Start Date2012-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0815-9 [71335081509]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-24

NDC 71335-0815-3 [71335081503]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-0 [71335081500]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-4 [71335081504]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-6 [71335081506]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-2 [71335081502]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-5 [71335081505]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-1 [71335081501]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-24

NDC 71335-0815-7 [71335081507]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-24

NDC 71335-0815-8 [71335081508]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-24

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:37de0550-a6d1-46a8-a0b8-447b0dcf70ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198052
  • 312086
  • 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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