NDC 0173-0489

ZOFRAN

Ondansetron Hydrochloride

ZOFRAN is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Ondansetron Hydrochloride.

Product ID0173-0489_611b5ddf-6ba0-4811-b040-29004102f56c
NDC0173-0489
Product TypeHuman Prescription Drug
Proprietary NameZOFRAN
Generic NameOndansetron Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1997-02-05
Marketing End Date2019-06-30
Marketing CategoryNDA / NDA
Application NumberNDA020605
Labeler NameGlaxoSmithKline LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/5mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0173-0489-00

50 mL in 1 BOTTLE, GLASS (0173-0489-00)
Marketing Start Date1997-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0489-00 [00173048900]

ZOFRAN SOLUTION
Marketing CategoryNDA
Application NumberNDA020605
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-02-05
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

OpenFDA Data

SPL SET ID:c7d61d98-fe86-4340-9b86-47eb92acaa0e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876693
  • 876690
  • 312085
  • 312086
  • 312087
  • 104896
  • 198052
  • 104894
  • 104895
  • 212447
    • UPC Code
  • 0301730569004
  • 0301730447005
  • 0301730446008

    • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "ZOFRAN" or generic name "Ondansetron Hydrochloride"

    NDCBrand NameGeneric Name
    0078-0675ZOFRANondansetron hydrochloride
    0078-0676ZOFRANondansetron hydrochloride
    0078-0679ZOFRANondansetron hydrochloride
    0078-0680ZOFRANondansetron hydrochloride
    0173-0447ZOFRANondansetron hydrochloride
    0173-0489ZOFRANondansetron hydrochloride
    80425-0113ZofranZofran
    80425-0075ZofranZofran
    80425-0072ZofranZofran
    80425-0073ZofranZofran
    0143-2422OndansetronOndansetron hydrochloride
    0143-2423OndansetronOndansetron hydrochloride
    0179-0099ondansetronondansetron hydrochloride
    0179-0100ondansetronondansetron hydrochloride
    16714-671OndansetronOndansetron Hydrochloride
    17856-0555OndansetronOndansetron Hydrochloride
    0054-0064Ondansetron HydrochlorideOndansetron Hydrochloride
    0179-0247Ondansetron HydrochlorideOndansetron Hydrochloride
    0179-0248Ondansetron HydrochlorideOndansetron Hydrochloride
    0527-1726Ondansetron HydrochlorideOndansetron Hydrochloride
    0615-8185ondansetron hydrochlorideondansetron hydrochloride
    0904-6551ondansetron hydrochlorideondansetron hydrochloride
    0904-6552ondansetron hydrochlorideondansetron hydrochloride
    10544-575Ondansetron HydrochlorideOndansetron Hydrochloride
    21695-834ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    21695-835ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE

    Trademark Results [ZOFRAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOFRAN
    ZOFRAN
    73670524 1592702 Live/Registered
    GLAXO GROUP LIMITED
    1987-07-06
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