kyzatrex

Generic: testosterone undecanoate

Labeler: marius pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kyzatrex
Generic Name testosterone undecanoate
Labeler marius pharmaceuticals
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

testosterone undecanoate 150 mg/1

Manufacturer
Marius Pharmaceuticals

Identifiers & Regulatory

Product NDC 80603-103
Product ID 80603-103_413922db-74d9-ab1f-e063-6394a90aba28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213953
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-07-27

Pharmacologic Class

Classes
androgen receptor agonists [moa] androgen [epc] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80603103
Hyphenated Format 80603-103

Supplemental Identifiers

RxCUI
2609597 2609603 2609605 2609607 2609609 2609611
UNII
H16A5VCT9C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kyzatrex (source: ndc)
Generic Name testosterone undecanoate (source: ndc)
Application Number NDA213953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-11)
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-22)
source: ndc

Packages (2)

80603-103-11 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-11) 80603-103-22 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-22)

Ingredients (1)

testosterone undecanoate (150 mg/1)

Linked Drug Pages (1)

Kyzatrex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "413922db-74d9-ab1f-e063-6394a90aba28", "openfda": {"unii": ["H16A5VCT9C"], "rxcui": ["2609597", "2609603", "2609605", "2609607", "2609609", "2609611"], "spl_set_id": ["7f7167a7-2a25-47e2-acf5-33f499fce971"], "manufacturer_name": ["Marius Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-11)", "package_ndc": "80603-103-11", "marketing_start_date": "20220727"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-103-22)", "package_ndc": "80603-103-22", "marketing_start_date": "20220727"}], "brand_name": "Kyzatrex", "product_id": "80603-103_413922db-74d9-ab1f-e063-6394a90aba28", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "80603-103", "dea_schedule": "CIII", "generic_name": "TESTOSTERONE UNDECANOATE", "labeler_name": "Marius Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kyzatrex", "active_ingredients": [{"name": "TESTOSTERONE UNDECANOATE", "strength": "150 mg/1"}], "application_number": "NDA213953", "marketing_category": "NDA", "marketing_start_date": "20220727", "listing_expiration_date": "20261231"}