Package 80603-103-22

Brand: kyzatrex

Generic: testosterone undecanoate
NDC Package

Package Facts

Identity

Package NDC 80603-103-22
Digits Only 8060310322
Product NDC 80603-103
Description

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

Marketing

Marketing Status
Marketed Since 2022-07-27
Brand kyzatrex
Generic testosterone undecanoate
Sample Package No

Linked Drug Pages (1)

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"}