NDC 69087-198

Jatenzo

Testosterone Undecanoate

Jatenzo is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Clarus Therapeutics, Inc.. The primary component is Testosterone Undecanoate.

Product ID69087-198_92470a45-8a11-69a6-e053-2a95a90a9e32
NDC69087-198
Product TypeHuman Prescription Drug
Proprietary NameJatenzo
Generic NameTestosterone Undecanoate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryNDA / NDA
Application NumberNDA206089
Labeler NameClarus Therapeutics, Inc.
Substance NameTESTOSTERONE UNDECANOATE
Active Ingredient Strength198 mg/1
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69087-198-12

12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69087-198-12 [69087019812]

Jatenzo CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA206089
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE UNDECANOATE198 mg/1

OpenFDA Data

SPL SET ID:ed7b5d41-7475-4c10-99b9-b62b3434ae60
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2121776
  • 2121766
  • 2121770
  • 2201642
  • 2201640
  • 2121768
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69087-158Jatenzotestosterone undecanoate
    69087-198Jatenzotestosterone undecanoate
    69087-237Jatenzotestosterone undecanoate
    67979-511Aveedtestosterone undecanoate
    80603-101KyzatrexTESTOSTERONE UNDECANOATE
    80603-103KyzatrexTESTOSTERONE UNDECANOATE
    80603-105KyzatrexTESTOSTERONE UNDECANOATE
    54436-112Tlandotestosterone undecanoate

    Trademark Results [Jatenzo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JATENZO
    JATENZO
    88379456 not registered Live/Pending
    Clarus Therapeutics, Inc.
    2019-04-10
    JATENZO
    JATENZO
    86756177 5019220 Live/Registered
    Clarus Therapeutics, Inc.
    2015-09-14

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