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 ID: 69087-198_92470a45-8a11-69a6-e053-2a95a90a9e32
• NDC: 69087-198
• Product Type: Human Prescription Drug
• Proprietary Name: Jatenzo
• Generic Name: Testosterone Undecanoate
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA206089
• Labeler Name: Clarus Therapeutics, Inc.
• Substance Name: TESTOSTERONE UNDECANOATE
• Active Ingredient Strength: 198 mg/1
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69087-198-12

12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69087-198-12 [69087019812]

Jatenzo CAPSULE, LIQUID FILLED

• Marketing Category: NDA
• Application Number: NDA206089
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE UNDECANOATE	198 mg/1

OpenFDA Data

• SPL SET ID: ed7b5d41-7475-4c10-99b9-b62b3434ae60
• Manufacturer:
  • Clarus Therapeutics, Inc.
• UNII:
  • H16A5VCT9C
• 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"

NDC	Brand Name	Generic Name
69087-158	Jatenzo	testosterone undecanoate
69087-198	Jatenzo	testosterone undecanoate
69087-237	Jatenzo	testosterone undecanoate
67979-511	Aveed	testosterone undecanoate
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE
54436-112	Tlando	testosterone undecanoate