Bixlenvo Sunlenca Starter Pack Kit
NDC Package 61958-3701-1

11-digit billing NDC: 61958370101
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bixlenvo Sunlenca Starter Pack (bictegravir/lenacapavir, lenacapavir sodium) kits is bIXLENVO SUNLENCA STARTER PACK is a co-packaged product containing BIXLENVO and SUNLENCA tablets and is indicated for the initiation of BIXLENVO, a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO [see Dosage and Administration (2.1) and Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-3701 and is authorized under FDA application NDA221443.

Identification & Billing

NDC Package Code
61958-3701-1
Package Description
1 KIT in 1 CARTON * 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-3) * 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-4)
Product Code
61958-3701
11-Digit Billing Format
61958370101

Clinical Specifications

Proprietary Name
Bixlenvo Sunlenca Starter Pack
Non-Proprietary Name
Bictegravir/lenacapavir, Lenacapavir Sodium
Dosage Form
Kit - A packaged collection of related material.
Usage Information
BIXLENVO SUNLENCA STARTER PACK is a co-packaged product containing BIXLENVO and SUNLENCA tablets and is indicated for the initiation of BIXLENVO, a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO [see Dosage and Administration (2.1) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA221443
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61958-3701-1 identifies a specific commercial package of 1 kit in 1 carton * 30 tablet, film coated in 1 bottle, plastic (61958-3601-3) * 4 tablet, film coated in 1 bottle, plastic (61958-3001-4) of Bixlenvo Sunlenca Starter Pack, 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 October 31, 2026. 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: 61958370101. 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)
61958-3701-1
11-Digit CMS (5-4-2)
61958-3701-01

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