Package 80603-105-11

Brand: kyzatrex

Generic: testosterone undecanoate
NDC Package

Package Facts

Identity

Package NDC 80603-105-11
Digits Only 8060310511
Product NDC 80603-105
Product ID 80603-105_413922db-74d9-ab1f-e063-6394a90aba28
Description

90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11)

Marketing

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

Linked Drug Pages (1)

Kyzatrex ndc-match (0.95)

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 (80603-105-11)", "package_ndc": "80603-105-11", "marketing_start_date": "20220727"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-22)", "package_ndc": "80603-105-22", "marketing_start_date": "20220727"}, {"sample": false, "description": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-33)", "package_ndc": "80603-105-33", "marketing_start_date": "20230925"}], "brand_name": "Kyzatrex", "product_id": "80603-105_413922db-74d9-ab1f-e063-6394a90aba28", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "80603-105", "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": "200 mg/1"}], "application_number": "NDA213953", "marketing_category": "NDA", "marketing_start_date": "20220727", "listing_expiration_date": "20261231"}