Cabenuva Kit
NDC Package 49702-253-15

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

Package Information

Cabenuva (cabotegravir and rilpivirine) kits is cABENUVA is indicated as 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 history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Clinical Studies (14.1)]. This formulation utilizes a kit delivery system. Marketed by Viiv Healthcare Company, this product is identified by NDC 49702-253 and is authorized under FDA application NDA212888.

Identification & Billing

NDC Package Code
49702-253-15
Package Description
1 KIT in 1 CARTON * 2 mL in 1 VIAL (49702-245-01) * 2 mL in 1 VIAL (49702-249-02)
Product Code
49702-253
11-Digit Billing Format
49702025315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2475415 - {1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack
  • RxCUI: 2475415 - cabotegravir 600 MG / rilpivirine 900 MG Extended Release Kit
  • RxCUI: 2475416 - {1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 600 MG / 900 MG]
  • RxCUI: 2475416 - CABENUVA 600 MG / 900 MG Extended Release Kit
  • RxCUI: 2475417 - {1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } Pack

Clinical Specifications

Proprietary Name
Cabenuva
Non-Proprietary Name
Cabotegravir And Rilpivirine
Dosage Form
Kit - A packaged collection of related material.
Usage Information
CABENUVA is indicated as 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 history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Clinical Studies (14.1)].

Regulatory & Marketing

Labeler Name
Viiv Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
NDA212888
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-21-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49702-253-15 identifies a specific commercial package of 1 kit in 1 carton * 2 ml in 1 vial (49702-245-01) * 2 ml in 1 vial (49702-249-02) of Cabenuva, a human prescription drug labeled by Viiv Healthcare Company. 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 Viiv Healthcare Company on January 21, 2021. The current certification is valid through December 31, 2026.

How is this Viiv Healthcare Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49702025315. 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 (5-3-2)
49702-253-15
11-Digit CMS (5-4-2)
49702-0253-15

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