NDC Package 61958-3001-1 Sunlenca

Lenacapavir Sodium Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61958-3001-1

Package Description:

1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK

Product Code:

61958-3001

Proprietary Name:

Sunlenca

Non-Proprietary Name:

Lenacapavir Sodium

Substance Name:

Lenacapavir Sodium

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.

11-Digit NDC Billing Format:

61958300101

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

1 EA

NDC to RxNorm Crosswalk:

RxCUI: 2625890 - lenacapavir 300 MG Oral Tablet
RxCUI: 2625890 - lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral Tablet
RxCUI: 2625896 - Sunlenca 300 MG Oral Tablet
RxCUI: 2625896 - lenacapavir 300 MG Oral Tablet [Sunlenca]
RxCUI: 2625897 - {4 (lenacapavir 300 MG Oral Tablet) } Pack

Product Type:

Human Prescription Drug

Labeler Name:

Gilead Sciences, Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

LENACAPAVIR SODIUM 300 mg/1

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

NDA215974

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

12-22-2022

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

61958 - Gilead Sciences, Inc.
- 61958-3001 - Sunlenca
  - 61958-3001-1 - 1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61958-3001-2	1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK
61958-3001-3	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61958-3001-1?

The NDC Packaged Code 61958-3001-1 is assigned to a package of 1 pouch in 1 carton / 1 blister pack in 1 pouch / 4 tablet, film coated in 1 blister pack of Sunlenca, a human prescription drug labeled by Gilead Sciences, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 61958-3001 included in the NDC Directory?

Yes, Sunlenca with product code 61958-3001 is active and included in the NDC Directory. The product was first marketed by Gilead Sciences, Inc. on December 22, 2022 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61958-3001-1?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 61958-3001-1?

The 11-digit format is 61958300101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	61958-3001-1	5-4-2	61958-3001-01

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