Label: ONDANSETRON tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 24, 2021

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  • DOSAGE FORMS & STRENGTHS

    Ondansetron Tablets USP, are available in the following strengths:4 mg – white, oval, film-coated tablets engraved with "4" on one side and “NO”on other side.8 mg – yellow, oval, film-coated tablets engraved with "8" on one side and "NO" on the other side.

  • PRINCIPAL DISPLAY PANEL

    Bottle Information

  • INGREDIENTS AND APPEARANCE
    ONDANSETRON 
    ondansetron tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80175-0017(NDC:71930-017)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON4 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 4;NO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80175-0017-530 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2018
    2NDC:80175-0017-110 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2018
    3NDC:80175-0017-660 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07785107/11/2018
    Labeler - Central Packaging (117617671)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Packaging, LLC117617671repack(80175-0017)