FDA.reportPublic FDA data

PEGLOTICASE

Substance profile for UNII R581OT55EA, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#

UNII
R581OT55EA
Preferred term
PEGLOTICASE
Registry number
885051-90-1
Ingredient type
INGREDIENT SUBSTANCE

Chemical And Database Identifiers#

RxCUI
1011650
PubChem
0
NCIt
C97466
INN ID
8934

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
RxNorm1011650mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1011650
NCI ThesaurusC97466ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C97466
FDA Substance Registration SystemR581OT55EAprecision.fda.gov/uniisearch/srs/unii/R581OT55EA

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYThese highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA ® (pegloticase) Injection, for intravenous infusion Initial U.S. Approval: 20105
ACTIVE INGREDIENTThese highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA ® (pegloticase) Injection, for intravenous infusion Initial U.S. Approval: 20105
ACTIVE INGREDIENTKRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [CREALTA PHARMACEUTICALS LLC]10
ACTIVE MOIETYKRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [CREALTA PHARMACEUTICALS LLC]10