NDC 68382-362

Testosterone

Testosterone

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

Product ID68382-362_266e9dfd-c1e6-e224-c0b2-68e0592f65d1
NDC68382-362
Product TypeHuman Prescription Drug
Proprietary NameTestosterone
Generic NameTestosterone
Dosage FormGel
Route of AdministrationTRANSDERMAL
Marketing Start Date2018-10-12
Marketing CategoryNDA AUTHORIZED GENERIC / NDA
Application NumberNDA022309
Labeler NameZydus Pharmaceuticals USA 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 68382-362-11

1 BOTTLE, PUMP in 1 CARTON (68382-362-11) > 88 g in 1 BOTTLE, PUMP
Marketing Start Date2018-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-362-11 [68382036211]

Testosterone GEL
Marketing CategoryNDA authorized generic
Application NumberNDA022309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-12

NDC 68382-362-13 [68382036213]

Testosterone GEL
Marketing CategoryNDA authorized generic
Application NumberNDA022309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-12

NDC 68382-362-14 [68382036214]

Testosterone GEL
Marketing CategoryNDA authorized generic
Application NumberNDA022309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-12

NDC 68382-362-12 [68382036212]

Testosterone GEL
Marketing CategoryNDA authorized generic
Application NumberNDA022309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-12

NDC 68382-362-15 [68382036215]

Testosterone GEL
Marketing CategoryNDA authorized generic
Application NumberNDA022309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-12

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE16.2 mg/g

OpenFDA Data

SPL SET ID:13c89fbb-f8e7-1f70-ef5a-468b90efb933
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1597126
  • 1597076
  • 1597120
    • UPC Code
  • 0368382362117
  • 0368382362155
  • 0368382362148

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382036215 TESTOSTERONE 1.62% (2.5 G) PKT

    Pricing Unit: GM | Drug Type:

    68382036211 TESTOSTERONE 1.62% GEL PUMP

    Pricing Unit: GM | Drug Type:

    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
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