krystexxa

Generic: pegloticase

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name krystexxa
Generic Name pegloticase
Labeler horizon therapeutics usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pegloticase 8 mg/50mL

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-058
Product ID 75987-058_fd7e64de-f906-4add-82d4-289bbc7ea2c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125293
Listing Expiration 2026-12-31
Marketing Start 2025-08-29

Pharmacologic Class

Established (EPC)
uric acid-specific enzyme [epc]
Chemical Structure
urate oxidase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987058
Hyphenated Format 75987-058

Supplemental Identifiers

RxCUI
1011653 1011657 2723378 2723381
UPC
0375987080100
UNII
R581OT55EA
NUI
M0022307 N0000175670

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name krystexxa (source: ndc)
Generic Name pegloticase (source: ndc)
Application Number BLA125293 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 8 mg/50mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (75987-058-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

pegloticase (8 mg/50mL)

Linked Drug Pages (1)

Krystexxa ndc-match (0.9)

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"}