Package 75987-058-01

Brand: krystexxa

Generic: pegloticase
NDC Package

Package Facts

Identity

Package NDC 75987-058-01
Digits Only 7598705801
Product NDC 75987-058
Product ID 75987-058_fd7e64de-f906-4add-82d4-289bbc7ea2c7
Description

1 VIAL in 1 CARTON (75987-058-01) / 50 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2025-08-29
Brand krystexxa
Generic pegloticase
Sample Package No

Linked Drug Pages (1)

Krystexxa ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fd7e64de-f906-4add-82d4-289bbc7ea2c7", "openfda": {"nui": ["M0022307", "N0000175670"], "upc": ["0375987080100"], "unii": ["R581OT55EA"], "rxcui": ["1011653", "1011657", "2723378", "2723381"], "spl_set_id": ["6e566303-d93a-4130-b764-25749829aa95"], "pharm_class_cs": ["Urate Oxidase [CS]"], "pharm_class_epc": ["Uric Acid-specific Enzyme [EPC]"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (75987-058-01)  / 50 mL in 1 VIAL", "package_ndc": "75987-058-01", "marketing_start_date": "20250829"}], "brand_name": "Krystexxa", "product_id": "75987-058_fd7e64de-f906-4add-82d4-289bbc7ea2c7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Urate Oxidase [CS]", "Uric Acid-specific Enzyme [EPC]"], "product_ndc": "75987-058", "generic_name": "pegloticase", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Krystexxa", "active_ingredients": [{"name": "PEGLOTICASE", "strength": "8 mg/50mL"}], "application_number": "BLA125293", "marketing_category": "BLA", "marketing_start_date": "20250829", "listing_expiration_date": "20261231"}