Lutrate Depot Kit
NDC Package 83831-134-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Lutrate Depot (leuprolide acetate) kits is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a kit delivery system. Marketed by Avyxa Pharma, Llc, this product is identified by NDC 83831-134 and is authorized under FDA application NDA205054.

Identification & Billing

NDC Package Code
83831-134-01
Package Description
1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)
Product Code
83831-134
11-Digit Billing Format
83831013401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lutrate Depot
Non-Proprietary Name
Leuprolide Acetate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

Regulatory & Marketing

Labeler Name
Avyxa Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205054
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-26-2025
Listing Expiration
12-31-2026
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.

J1954
Source: PDAC
INJECTION, LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (LUTRATE DEPOT), 7.5 MG
HCPCS Dosage 7.5 MG
Units / Pkg

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 83831-134-01 identifies a specific commercial package of 1 kit in 1 carton * 2 ml in 1 vial, single-dose (83831-150-22) * 2 ml in 1 syringe (83831-135-02) of Lutrate Depot, a human prescription drug labeled by Avyxa Pharma, Llc. This kit is formulated for use and contains 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 Avyxa Pharma, Llc on March 26, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

How is this Avyxa Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83831013401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
83831-134-01
11-Digit CMS (5-4-2)
83831-0134-01

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