NDC 69654-239

Natesto

Testosterone

Natesto is a Nasal Gel in the Human Prescription Drug category. It is labeled and distributed by Aytu Bioscience, Inc.. The primary component is Testosterone.

Product ID69654-239_23a44b91-1f72-4304-89e3-d68626736fae
NDC69654-239
Product TypeHuman Prescription Drug
Proprietary NameNatesto
Generic NameTestosterone
Dosage FormGel
Route of AdministrationNASAL
Marketing Start Date2017-09-01
Marketing CategoryNDA / NDA
Application NumberNDA205488
Labeler NameAytu BioScience, Inc.
Substance NameTESTOSTERONE
Active Ingredient Strength6 mg/1
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69654-239-01

1 BOTTLE, PUMP in 1 CARTON (69654-239-01) > 60 GEL in 1 BOTTLE, PUMP
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69654-239-01 [69654023901]

Natesto GEL
Marketing CategoryNDA
Application NumberNDA205488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-09-01

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE5.5 mg/1

OpenFDA Data

SPL SET ID:68d0447b-f75a-4fb2-96ba-de822b74aebb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1596784
  • 1596782
  • UPC Code
  • 0369654239014
  • Pharmacological Class

    • Androgen [EPC]
    • Androgen Receptor Agonists [MoA]
    • Androstanes [CS]

    Medicade Reported Pricing

    69654023901 NATESTO NASAL 5.5 MG/0.122 GM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Natesto" or generic name "Testosterone"

    NDCBrand NameGeneric Name
    69654-239NatestoNatesto
    0023-5990AndrodermTestosterone
    0023-5992AndrodermTestosterone
    0051-8425AndrogelTestosterone
    0051-8450AndrogelTestosterone
    0051-8462AndrogelTestosterone
    0254-1012Testosteronetestosterone
    0591-2114TestosteroneTestosterone
    0591-2363Testosteronetestosterone
    0591-2921TestosteroneTestosterone
    0591-2924TestosteroneTestosterone
    0591-2925TestosteroneTestosterone
    0591-2926TestosteroneTestosterone
    0591-3216TestosteroneTestosterone
    0245-0871VogelxoTestosterone
    0245-0872VogelxoTestosterone

    Trademark Results [Natesto]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NATESTO
    NATESTO
    86084664 4761006 Live/Registered
    Trimel BioPharma SRL
    2013-10-07

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