NDC 80603-101

Kyzatrex

Testosterone Undecanoate

Kyzatrex is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Marius Pharmaceuticals. The primary component is Testosterone Undecanoate.

• Product ID: 80603-101_3b31326b-606a-4fc9-9432-00775cfd05af
• NDC: 80603-101
• Product Type: Human Prescription Drug
• Proprietary Name: Kyzatrex
• Generic Name: Testosterone Undecanoate
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2022-07-27
• Marketing Category: NDA /
• Application Number: NDA213953
• Labeler Name: Marius Pharmaceuticals
• Substance Name: TESTOSTERONE UNDECANOATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 80603-101-11

90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11)

• Marketing Start Date: 2022-07-27
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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

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