NDC 24979-078

Testosterone

Testosterone

Testosterone is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Twi Pharmaceuticals, Inc.. The primary component is Testosterone.

Product ID24979-078_493f1d38-8503-46a3-a728-0cb728d12629
NDC24979-078
Product TypeHuman Prescription Drug
Proprietary NameTestosterone
Generic NameTestosterone
Dosage FormGel
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA209390
Labeler NameTWi Pharmaceuticals, Inc.
Substance NameTESTOSTERONE
Active Ingredient Strength16 mg/g
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24979-078-15

1 BOTTLE, PUMP in 1 CARTON (24979-078-15) > 88 g in 1 BOTTLE, PUMP
Marketing Start Date2019-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24979-078-15 [24979007815]

Testosterone GEL
Marketing CategoryANDA
Application NumberANDA209390
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE16.2 mg/g

OpenFDA Data

SPL SET ID:10dab294-6a43-4bb3-9d91-2d200c624ffb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1597076
    • UPC Code
  • 0324979078151

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0254-1012Testosteronetestosterone
    0591-2114TestosteroneTestosterone
    0591-2363Testosteronetestosterone
    0591-2921TestosteroneTestosterone
    0591-2924TestosteroneTestosterone
    0591-2925TestosteroneTestosterone
    0591-2926TestosteroneTestosterone
    0591-3216TestosteroneTestosterone
    68180-943TestosteroneTestosterone
    68382-362TestosteroneTestosterone
    69097-363TestosteroneTestosterone
    0591-3217TestosteroneTestosterone
    70518-1171TestosteroneTestosterone
    0591-3524TestosteroneTestosterone
    0603-7831TestosteroneTestosterone
    0832-1121TestosteroneTestosterone
    0832-1120TestosteroneTestosterone
    43742-1242TestosteroneTestosterone
    43742-0021TestosteroneTestosterone
    43853-0021TestosteroneTestosterone
    43742-0677TestosteroneTestosterone
    44117-0002TestosteroneTestosterone
    43853-0005TestosteroneTestosterone
    44117-0001TestosteroneTestosterone
    45802-116TestosteroneTestosterone
    45802-754testosteronetestosterone
    45802-610testosteronetestosterone
    49884-510TestosteroneTestosterone
    49884-418TestosteroneTestosterone
    50845-0113TestosteroneTestosterone
    57520-0638TestosteroneTestosterone
    68180-941TestosteroneTestosterone
    43598-304TestosteroneTestosterone
    69238-1013TestosteroneTestosterone
    45802-281testosteronetestosterone
    45802-366testosteronetestosterone
    0023-5990AndrodermTestosterone
    0023-5992AndrodermTestosterone
    0051-8425AndrogelTestosterone
    0051-8450AndrogelTestosterone
    0051-8462AndrogelTestosterone
    0245-0871VogelxoTestosterone
    0245-0872VogelxoTestosterone

    Trademark Results [Testosterone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TESTOSTERONE
    TESTOSTERONE
    97235300 not registered Live/Pending
    Diba Imports, L.P.
    2022-01-24
    TESTOSTERONE
    TESTOSTERONE
    88467188 not registered Live/Pending
    Helix Mobile Wellness and Research LLC
    2019-06-10
    TESTOSTERONE
    TESTOSTERONE
    87371715 not registered Dead/Abandoned
    Diba Imports L.P.
    2017-03-15
    TESTOSTERONE
    TESTOSTERONE
    87353999 not registered Dead/Abandoned
    WALTERS & MASON RETAIL, INC.
    2017-03-01
    TESTOSTERONE
    TESTOSTERONE
    86295529 4865308 Live/Registered
    Monsterops LLC
    2014-05-29
    TESTOSTERONE
    TESTOSTERONE
    85718802 4766706 Live/Registered
    Testosterone Aspen, LLC
    2012-08-31
    TESTOSTERONE
    TESTOSTERONE
    85610579 4485777 Live/Registered
    Diba Imports, L.P.
    2012-04-27
    TESTOSTERONE
    TESTOSTERONE
    85056174 not registered Dead/Abandoned
    Chen, Candace
    2010-06-07
    TESTOSTERONE
    TESTOSTERONE
    75513228 2358489 Dead/Cancelled
    PATTERSON, TIM ALLYN
    1998-07-06
    TESTOSTERONE
    TESTOSTERONE
    75294102 2817618 Dead/Cancelled
    MONSTEROPS LLC
    1997-05-19
    TESTOSTERONE
    TESTOSTERONE
    75229319 2103641 Dead/Cancelled
    HARD CANDY, INC.
    1997-01-22
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.