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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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 2026-06-01
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