Apretude Kit
NDC Package 49702-280-63

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

Package Information

Apretude (cabotegravir) kits is aPRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. This formulation utilizes a kit delivery system. Marketed by Viiv Healthcare Company, this product is identified by NDC 49702-280 and is authorized under FDA application NDA215499.

Identification & Billing

NDC Package Code
49702-280-63
Package Description
1 KIT in 1 CARTON * 3 mL in 1 VIAL (49702-238-61)
Product Code
49702-280
11-Digit Billing Format
49702028063
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Apretude
Non-Proprietary Name
Cabotegravir
Dosage Form
Kit - A packaged collection of related material.
Usage Information
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP [see Dosage and Administration (2.2, 2.4), Contraindications (4), Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Viiv Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
NDA215499
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-31-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 49702-280-63 identifies a specific commercial package of 1 kit in 1 carton * 3 ml in 1 vial (49702-238-61) of Apretude, 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 March 31, 2024. 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: 49702028063. 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)
49702-280-63
11-Digit CMS (5-4-2)
49702-0280-63

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