FDA.reportPublic FDA data

Krystexxa

Product NDC
75987-058
Requested package NDC
75987-058-01
11-digit product format
759870058
Labeler code
75987
Product ID
75987-058_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
2025-08-29
Substance
PEGLOTICASE
Active strength
8 mg/50mL
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
IngredientStrength
PEGLOTICASE8 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R581OT55EAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011653Internal RxNorm lookup
1011657Internal RxNorm lookup
2723378Internal RxNorm lookup
2723381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e566303-d93a-4130-b764-25749829aa95Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75987-058-01Krystexxa1 in 1 CARTONINJECTION, SOLUTION11142
75987-058-01Krystexxa50 mL in 1 VIALINJECTION, SOLUTION501142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-058-01ML - Milliliter75987-058482cd7c2-b244-4d3c-a7c1-f98f5fd501f512025-10-14

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KrystexxaPEGLOTICASEHorizon Therapeutics USA, Inc.6e566303-d93a-4130-b764-25749829aa952026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125293
ndc (package): 75987-058-01
ndc (product): 75987-058
ndc11 (package): 75987005801

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125293Krystexxapegloticase351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011657Krystexxa 8 MG in 1 ML InjectionPSN6e566303-d93a-4130-b764-25749829aa951143
2723381KRYSTEXXA 8 MG in 50 ML InjectionPSN6e566303-d93a-4130-b764-25749829aa951143
1011653pegloticase 8 MG in 1 ML InjectionPSN6e566303-d93a-4130-b764-25749829aa951143
2723378pegloticase 8 MG in 50 ML InjectionPSN6e566303-d93a-4130-b764-25749829aa951143
10116571 ML pegloticase 8 MG/ML Injection [Krystexxa]SBD6e566303-d93a-4130-b764-25749829aa951143
272338150 ML pegloticase 0.16 MG/ML Injection [Krystexxa]SBD6e566303-d93a-4130-b764-25749829aa951143
10116531 ML pegloticase 8 MG/ML InjectionSCD6e566303-d93a-4130-b764-25749829aa951143
272337850 ML pegloticase 0.16 MG/ML InjectionSCD6e566303-d93a-4130-b764-25749829aa951143
1011657Krystexxa (as uricase protein) 8 MG per 1 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143
1011657Krystexxa 8 MG per 1 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143
2723381Krystexxa 8 MG per 50 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143
1011653pegloticase (as uricase protein) 8 MG per 1 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143
1011653pegloticase 8 MG per 1 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143
2723378pegloticase 8 MG per 50 ML InjectionSY6e566303-d93a-4130-b764-25749829aa951143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75987-058-01759870058011 VIAL in 1 CARTON (75987-058-01) / 50 mL in 1 VIAL1 vial2025-08-29NoNoCurrent