Home NDC 75987-080-10 Krystexxa
Product NDC 75987-080
Requested package NDC 75987-080-10
11-digit product format 759870080
Labeler code 75987
Product ID 75987-080_0391b7f8-de21-41a5-b125-aace02db52b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pegloticase
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Horizon Therapeutics USA, Inc.
Application BLA125293
Marketing category BLA
Marketing start 2010-09-14
Substance PEGLOTICASE
Active strength 8 mg/mL
Pharmacologic classes Urate Oxidase [CS], Uric Acid-specific Enzyme [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Krystexxa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEGLOTICASE 8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R581OT55EA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011653 Internal RxNorm lookup 1011657 Internal RxNorm lookup 2723378 Internal RxNorm lookup 2723381 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75987-080-10 Krystexxa 1 mL in 1 VIAL INJECTION, SOLUTION 1 1142 75987-080-10 Krystexxa 1 in 1 CARTON INJECTION, SOLUTION 1 1142
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75987-080 KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.] 1140 Current NDC, Legacy NDC, 2 package rows 20250424_6e566303-d93a-4130-b764-25749829aa95.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125293 Krystexxa pegloticase 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75987-080-10 75987008010 1 VIAL in 1 CARTON (75987-080-10) / 1 mL in 1 VIAL 1 vial 2010-09-14 0000-00-00 No No Current