Package 80725-810-10

Brand: hydrea

Generic: hydroxyurea
NDC Package

Package Facts

Identity

Package NDC 80725-810-10
Digits Only 8072581010
Product NDC 80725-810
Description

100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)

Marketing

Marketing Status
Marketed Since 2025-09-11
Brand hydrea
Generic hydroxyurea
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d30874b9-8639-44b3-a91b-4fcce90ca484", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0380725810109"], "unii": ["X6Q56QN5QC"], "rxcui": ["105602", "197797"], "spl_set_id": ["8d41152f-a98a-4abc-afdf-a909012434a0"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)", "package_ndc": "80725-810-10", "marketing_start_date": "20250911"}], "brand_name": "HYDREA", "product_id": "80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "80725-810", "generic_name": "Hydroxyurea", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "NDA016295", "marketing_category": "NDA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}