Loargys Injection
NDC Package 81583-102-01

11-digit billing NDC: 81583010201 · Billing unit: ML · 0.4 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Loargys (pegzilarginase-nbln) injection is lOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies (14)]. This formulation utilizes a injection delivery system. Marketed by Immedica Pharma Us Inc., this product is identified by NDC 81583-102 and is authorized under FDA application BLA761211.

Identification & Billing

NDC Package Code
81583-102-01
Package Description
1 VIAL in 1 CARTON / .4 mL in 1 VIAL
Product Code
81583-102
11-Digit Billing Format
81583010201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
0.4 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loargys
Non-Proprietary Name
Pegzilarginase-nbln
Substance Name
Pegzilarginase
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PEGZILARGINASE 2 mg/.4mL
Usage Information
LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Immedica Pharma Us Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761211
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-09-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1818
Source: OPPS
Inj pegzilarginase-nbln
HCPCS Dosage 0.05 MG
Units / Pkg 40

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81583-102-01 identifies a specific commercial package of 1 vial in 1 carton / .4 ml in 1 vial of Loargys, a human prescription drug labeled by Immedica Pharma Us Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 0.4 billable units per package. This injection is formulated for intravenous; subcutaneous use and contains pegzilarginase as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Immedica Pharma Us Inc. on March 09, 2026. The current certification is valid through December 31, 2027.

How is this Immedica Pharma Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81583010201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 0.4 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81583-102-01
11-Digit CMS (5-4-2)
81583-0102-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.