Package 0003-4160-60

Brand: augtyro

Generic: repotrectinib
NDC Package

Package Facts

Identity

Package NDC 0003-4160-60
Digits Only 0003416060
Product NDC 0003-4160
Description

60 CAPSULE in 1 BOTTLE (0003-4160-60)

Marketing

Marketing Status
Marketed Since 2024-11-01
Brand augtyro
Generic repotrectinib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "03987a7d-5ac9-4c41-9a48-c9aee4dd13de", "openfda": {"nui": ["N0000175605", "N0000194093", "N0000194094", "N0000194095", "N0000194096", "N0000185506"], "upc": ["0300000000001"], "unii": ["08O3FQ4UNP"], "rxcui": ["2670649", "2670655", "2696876", "2696878"], "spl_set_id": ["fb526827-40ba-4462-94cf-179ae3b0cb8a"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (0003-4160-14)", "package_ndc": "0003-4160-14", "marketing_start_date": "20241101"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0003-4160-60)", "package_ndc": "0003-4160-60", "marketing_start_date": "20241101"}], "brand_name": "Augtyro", "product_id": "0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Kinase Inhibitor [EPC]", "Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]"], "product_ndc": "0003-4160", "generic_name": "repotrectinib", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Augtyro", "active_ingredients": [{"name": "REPOTRECTINIB", "strength": "160 mg/1"}], "application_number": "NDA218213", "marketing_category": "NDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}