Home NDC 81583-105 Loargys
Product NDC 81583-105
11-digit product format 815830105
Labeler code 81583
Product ID 81583-105_d5ceabf2-43a0-4746-9371-d98a39cf6cfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pegzilarginase-nbln
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Immedica Pharma US Inc.
Application BLA761211
Marketing category BLA
Marketing start 2026-03-09
Substance PEGZILARGINASE
Active strength 5 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loargys
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEGZILARGINASE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4YV4KW88GD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2738655 Internal RxNorm lookup 2738662 Internal RxNorm lookup 2738664 Internal RxNorm lookup 2738665 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81583-105-01 Loargys 1 mL in 1 VIAL INJECTION 1 1 81583-105-01 Loargys 1 in 1 CARTON INJECTION 1 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loargys PEGZILARGINASE-NBLN Immedica Pharma US Inc. d5ceabf2-43a0-4746-9371-d98a39cf6cfc 2026-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761211 ndc (product): 81583-105
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761211 Loargys pegzilarginase-nbln 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 81583-105-01 81583010501 1 mL in 1 VIAL 1 ml Historical