Package 65597-407-28
Brand: turalio
Generic: pexidartinib hydrochloridePackage Facts
Identity
Package NDC
65597-407-28
Digits Only
6559740728
Product NDC
65597-407
Description
1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE
Marketing
Marketing Status
Brand
turalio
Generic
pexidartinib hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "00774850-56e9-4fb9-85e8-586967a9a5f1", "openfda": {"unii": ["YS6WAI3XN7"], "rxcui": ["2626397", "2626399"], "spl_set_id": ["7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE", "package_ndc": "65597-407-20", "marketing_start_date": "20230201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE", "package_ndc": "65597-407-28", "marketing_start_date": "20230201"}], "brand_name": "Turalio", "product_id": "65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1", "dosage_form": "CAPSULE", "pharm_class": ["Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "Tyrosine Kinase Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]"], "product_ndc": "65597-407", "generic_name": "pexidartinib hydrochloride", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Turalio", "active_ingredients": [{"name": "PEXIDARTINIB HYDROCHLORIDE", "strength": "125 mg/1"}], "application_number": "NDA211810", "marketing_category": "NDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}