NDC 69654-510

ZOLPIMIST

Zolpidem Tartrate

ZOLPIMIST is a Oral Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Aytu Bioscience, Inc.. The primary component is Zolpidem Tartrate.

Product ID69654-510_4c487110-fe30-4b65-a49b-cc5aff52e045
NDC69654-510
Product TypeHuman Prescription Drug
Proprietary NameZOLPIMIST
Generic NameZolpidem Tartrate
Dosage FormSpray, Metered
Route of AdministrationORAL
Marketing Start Date2019-02-26
Marketing CategoryNDA / NDA
Application NumberNDA022196
Labeler NameAytu BioScience, Inc.
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength5 mg/1
Pharm Classesgamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69654-510-30

1 BOTTLE, SPRAY in 1 CARTON (69654-510-30) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date2019-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69654-510-60 [69654051060]

ZOLPIMIST SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022196
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-26

NDC 69654-510-30 [69654051030]

ZOLPIMIST SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022196
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-26

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

OpenFDA Data

SPL SET ID:7b99e2ac-ff5b-c07a-e053-2a91aa0a6ade
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828692
  • 828696
  • UPC Code
  • 0369654510304
  • 0369654510601
  • Pharmacological Class

    • gamma-Aminobutyric Acid-ergic Agonist [EPC]
    • GABA A Agonists [MoA]
    • Pyridines [CS]
    • Central Nervous System Depression [PE]

    NDC Crossover Matching brand name "ZOLPIMIST" or generic name "Zolpidem Tartrate"

    NDCBrand NameGeneric Name
    69654-510ZOLPIMISTZOLPIMIST
    58407-510ZolpiMISTZolpiMIST
    0024-5401Ambienzolpidem tartrate
    0024-5421Ambienzolpidem tartrate
    0024-5501Ambienzolpidem tartrate
    0024-5521Ambienzolpidem tartrate
    0037-6010EdluarZolpidem Tartrate
    0037-6050EdluarZolpidem Tartrate
    0054-0086Zolpidem Tartratezolpidem tartrate
    0054-0087Zolpidem Tartratezolpidem tartrate
    0093-0073Zolpidem TartrateZolpidem Tartrate
    0093-0074Zolpidem TartrateZolpidem Tartrate

    Trademark Results [ZOLPIMIST]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOLPIMIST
    ZOLPIMIST
    88016434 5684905 Live/Registered
    Aytu BioScience, Inc.
    2018-06-26
    ZOLPIMIST
    ZOLPIMIST
    88013915 5689515 Live/Registered
    AYTU BIOSCIENCE, INC.
    2018-06-25
    ZOLPIMIST
    ZOLPIMIST
    77176611 3958019 Dead/Cancelled
    AMHERST PHARMACEUTICALS
    2007-05-09

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