Sunlenca Tablet, Film Coated
NDC Package 61958-3001-3

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

Package Information

Sunlenca (lenacapavir sodium) tablets is sUNLENCA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. This formulation utilizes a tablet, film coated delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-3001 and is authorized under FDA application NDA215974.

Identification & Billing

NDC Package Code
61958-3001-3
Package Description
4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
61958-3001
11-Digit Billing Format
61958300103
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sunlenca
Non-Proprietary Name
Lenacapavir Sodium
Substance Name
Lenacapavir Sodium
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LENACAPAVIR SODIUM 300 mg/1
Pharmacologic Class
Usage Information
SUNLENCA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215974
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-22-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61958-3001). Click a package code to view its specific billing and regulatory data.

61958-3001-1
1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK
61958-3001-2
1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK

* 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 61958-3001-3 identifies a specific commercial package of 4 tablet, film coated in 1 bottle, plastic of Sunlenca, a human prescription drug labeled by Gilead Sciences, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This tablet, film coated is formulated for oral use and contains lenacapavir sodium 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 December 22, 2022. 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: 61958300103. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 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 (5-4-1)
61958-3001-3
11-Digit CMS (5-4-2)
61958-3001-03

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