FDA.reportPublic FDA data

Loargys 5 MG per 1 ML Injection

RxCUI
2738662
RxNorm name
Loargys 5 MG per 1 ML Injection
Display name
Loargys 5 MG per 1 ML Injection
Full name
Loargys 5 MG per 1 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761211Loargyspegzilarginase-nbln351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
LoargysPEGZILARGINASE-NBLNImmedica Pharma US Inc.d5ceabf2-43a0-4746-9371-d98a39cf6cfc2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2738662

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d5ceabf2-43a0-4746-9371-d98a39cf6cfcLoargys 5 MG in 1 ML Injection [PSN] · 1 ML pegzilarginase-nbln 5 MG/ML Injection [Loargys] [SBD] · Loargys 5 MG per 1 ML Injection [SY] · Loargys 5 MG/ML per 1 ML Injection [SY]41These highlights do not include all the information needed to use LOARGYS safely and effectively. See full prescribing information for LOARGYS . LOARGYS (pegzilarginase-nbln) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202620260223