Vocabria Tablet, Film Coated
NDC Package 49702-248-13

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

Package Information

Vocabria (cabotegravir sodium) tablets is vOCABRIA is indicated in combination with EDURANT (rilpivirine) for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as [see Dosage and Administration (2.1)]:•oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension, a component of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions. This formulation utilizes a tablet, film coated delivery system. Marketed by Viiv Healthcare Company, this product is identified by NDC 49702-248 and is authorized under FDA application NDA212887.

Identification & Billing

NDC Package Code
49702-248-13
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
49702-248
11-Digit Billing Format
49702024813
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vocabria
Non-Proprietary Name
Cabotegravir Sodium
Substance Name
Cabotegravir 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)
CABOTEGRAVIR SODIUM 30 mg/1
Pharmacologic Class
Usage Information
VOCABRIA is indicated in combination with EDURANT (rilpivirine) for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as [see Dosage and Administration (2.1)]:•oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension, a component of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions. •oral therapy for patients who will miss planned injection dosing with CABENUVA.

Regulatory & Marketing

Labeler Name
Viiv Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
NDA212887
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49702-248-13 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Vocabria, a human prescription drug labeled by Viiv Healthcare Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains cabotegravir 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 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: 49702024813. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-3-2)
49702-248-13
11-Digit CMS (5-4-2)
49702-0248-13

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