Yeztugo Kit
NDC Package 61958-3402-1

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

Yeztugo (lenacapavir sodium) kits is yEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. This formulation utilizes a kit delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-3402 and is authorized under FDA application NDA220018.

Identification & Billing

NDC Package Code
61958-3402-1
Package Description
1 KIT in 1 CARTON * 1.5 mL in 1 VIAL (61958-3403-1)
Product Code
61958-3402
11-Digit Billing Format
61958340201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Yeztugo
Non-Proprietary Name
Lenacapavir Sodium
Dosage Form
Kit - A packaged collection of related material.
Usage Information
YEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA220018
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2025
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.

J0738
Source: PREP
Hiv prep, inj, lenacapavir
HCPCS Dosage 1 MG
Units / Pkg 927

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 61958-3402-1 identifies a specific commercial package of 1 kit in 1 carton * 1.5 ml in 1 vial (61958-3403-1) of Yeztugo, a human prescription drug labeled by Gilead Sciences, Inc.. 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 Gilead Sciences, Inc. on June 18, 2025. The current certification is valid through December 31, 2027.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958340201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
61958-3402-1
11-Digit CMS (5-4-2)
61958-3402-01

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