NDC 89141-448

ZUPLENZ

Ondansetron

ZUPLENZ is a Oral Film in the Human Prescription Drug category. It is labeled and distributed by Midatech Pharma Us, Inc.. The primary component is Ondansetron.

Product ID89141-448_741a7179-ed5b-4301-83cc-b1145c53a916
NDC89141-448
Product TypeHuman Prescription Drug
Proprietary NameZUPLENZ
Generic NameOndansetron
Dosage FormFilm
Route of AdministrationORAL
Marketing Start Date2010-07-02
Marketing CategoryNDA / NDA
Application NumberNDA022524
Labeler NameMidatech Pharma US, Inc.
Substance NameONDANSETRON
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 89141-448-30

30 POUCH in 1 BOX (89141-448-30) > 1 FILM in 1 POUCH (89141-448-01)
Marketing Start Date2016-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 89141-448-30 [89141044830]

ZUPLENZ FILM
Marketing CategoryNDA
Application NumberNDA022524
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-31

NDC 89141-448-01 [89141044801]

ZUPLENZ FILM
Marketing CategoryNDA
Application NumberNDA022524
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-02

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON8 mg/1

OpenFDA Data

SPL SET ID:0b1dab95-b64b-4133-bcad-a65b332ab320
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998028
  • 998032
  • 998035
  • 998033
    • UPC Code
  • 0389141444301
  • 0389141448309

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ZUPLENZ" or generic name "Ondansetron"

    NDCBrand NameGeneric Name
    89141-444ZUPLENZZUPLENZ
    89141-448ZUPLENZZUPLENZ
    0143-2424OndansetronOndansetron
    0143-9890OndansetronOndansetron
    0143-9891OndansetronOndansetron
    0378-0315Ondansetronondansetron
    0378-0344Ondansetronondansetron
    0378-0374Ondansetronondansetron
    0378-7732OndansetronOndansetron
    0378-7734OndansetronOndansetron
    0404-9930ONDANSETRONONDANSETRON
    0409-1120OndansetronONDANSETRON
    0409-4755OndansetronONDANSETRON
    0409-4759OndansetronONDANSETRON
    0641-6078OndansetronOndansetron
    0641-6079OndansetronOndansetron
    0641-6080OndansetronOndansetron
    0781-1679OndansetronOndansetron
    0781-1681OndansetronOndansetron

    Trademark Results [ZUPLENZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZUPLENZ
    ZUPLENZ
    77650407 3877508 Live/Registered
    AQUESTIVE THERAPEUTICS, INC.
    2009-01-15
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