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United States · US · US:75987-058_2dd473d6-523f-404c-b587-80a1656dae95
Krystexxa
UNIISPLATC M04AX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHorizon Therapeutics USA, Inc.
CountryUS (United States)
ATC codeM04AX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1175987058011 VIAL in 1 CARTON (75987-058-01) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
R581OT55EA
PEGLOTICASE
RxCUI 1011650
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R581OT55EA",
"rxcui": "1011650",
"inchikey": null,
"display_name": "PEGLOTICASE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"6e566303-d93a-4130-b764-25749829aa95": {
"match": "brand_token",
"title": "KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.]",
"spl_version": "1143",
"published_date": "2026-06-01"
}
},
"productid": "75987-058_2dd473d6-523f-404c-b587-80a1656dae95",
"productndc": "75987-058",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PEGLOTICASE",
"proprietary_name": "Krystexxa",
"active_ingred_unit": "mg/50mL",
"application_number": "BLA125293",
"marketing_category": "BLA",
"nonproprietary_name": "pegloticase",
"start_marketing_date": "20250829",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code M04AX02.
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