Rukobia Tablet, Film Coated, Extended Release
NDC Package 49702-250-18

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

Package Information

Rukobia (fostemsavir tromethamine) tablets is rUKOBIA, 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 [see Clinical Studies (14)]. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Viiv Healthcare Company, this product is identified by NDC 49702-250 and is authorized under FDA application NDA212950.

Identification & Billing

NDC Package Code
49702-250-18
Package Description
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
49702-250
11-Digit Billing Format
49702025018
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2380549 - fostemsavir 600 MG 12HR Extended Release Oral Tablet
  • RxCUI: 2380549 - 12 HR fostemsavir 600 MG Extended Release Oral Tablet
  • RxCUI: 2380549 - 12 HR fostemsavir 600 MG (equivalent to 725 MG fostemsavir tromethamine) Extended Release Oral Tablet
  • RxCUI: 2380549 - fostemsavir 600 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 2380551 - Rukobia 600 MG 12HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Rukobia
Non-Proprietary Name
Fostemsavir Tromethamine
Substance Name
Fostemsavir Tromethamine
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSTEMSAVIR TROMETHAMINE 600 mg/1
Usage Information
RUKOBIA, 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 [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Viiv Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
NDA212950
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-02-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49702-250-18 identifies a specific commercial package of 1 bottle in 1 carton / 60 tablet, film coated, extended release in 1 bottle of Rukobia, a human prescription drug labeled by Viiv Healthcare Company. This tablet, film coated, extended release is formulated for oral use and contains fostemsavir tromethamine 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 July 02, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49702025018. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
49702-250-18
11-Digit CMS (5-4-2)
49702-0250-18

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