Package 62484-0015-5

Brand: xromi

Generic: hydroxyurea
NDC Package

Package Facts

Identity

Package NDC 62484-0015-5
Digits Only 6248400155
Product NDC 62484-0015
Description

1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)

Marketing

Marketing Status
Marketed Since 2024-04-04
Brand xromi
Generic hydroxyurea
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6eb58656-a29b-4edb-966f-bc9a13a78775", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0362484001547"], "unii": ["X6Q56QN5QC"], "rxcui": ["2682741", "2696079"], "spl_set_id": ["4b37d336-86da-4363-aef1-34a7d3ba973b"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Nova Laboratories, Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62484-0015-5)  / 148 mL in 1 BOTTLE (62484-0015-4)", "package_ndc": "62484-0015-5", "marketing_start_date": "20240404"}], "brand_name": "XROMI", "product_id": "62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775", "dosage_form": "SOLUTION", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "62484-0015", "generic_name": "Hydroxyurea", "labeler_name": "Nova Laboratories, Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XROMI", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "100 mg/mL"}], "application_number": "NDA216593", "marketing_category": "NDA", "marketing_start_date": "20240404", "listing_expiration_date": "20271231"}