NDC 0078-0680

ZOFRAN ODT

Ondansetron Hydrochloride

ZOFRAN ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ondansetron.

Product ID0078-0680_1ae5aba7-0e8c-40d6-9537-ceb096c07cda
NDC0078-0680
Product TypeHuman Prescription Drug
Proprietary NameZOFRAN ODT
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2017-08-23
Marketing CategoryNDA / NDA
Application NumberNDA020781
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameONDANSETRON
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 0078-0680-19

30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0680-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0078-0680-61)
Marketing Start Date2017-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0680-19 [00078068019]

ZOFRAN ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA020781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-23
Marketing End Date2019-10-31

NDC 0078-0680-61 [00078068061]

ZOFRAN ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA020781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-23
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON8 mg/1

OpenFDA Data

SPL SET ID:555f81bc-4ce0-4f77-b394-b974838c4440
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876693
  • 876690
  • 312086
  • 312087
  • 104896
  • 198052
  • 104894
  • 104895
    • UPC Code
  • 0300780676151
  • 0300780675154

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0078-0675ZOFRANondansetron hydrochloride
    0078-0676ZOFRANondansetron hydrochloride
    0078-0679ZOFRANondansetron hydrochloride
    0078-0680ZOFRANondansetron hydrochloride
    0173-0447ZOFRANondansetron hydrochloride
    0173-0489ZOFRANondansetron 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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