NDC Package 49702-250-18 Rukobia

Fostemsavir Tromethamine Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

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:
49702-250-18
Package Description:
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Rukobia
Non-Proprietary Name:
Fostemsavir Tromethamine
Substance Name:
Fostemsavir Tromethamine
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)].
11-Digit NDC Billing Format:
49702025018
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: 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
Product Type:
Human Prescription Drug
Labeler Name:
Viiv Healthcare Company
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(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
NDA212950
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
07-02-2020
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 NDC 49702-250-18?

The NDC Packaged Code 49702-250-18 is assigned to a 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. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Is NDC 49702-250 included in the NDC Directory?

Yes, Rukobia with product code 49702-250 is active and included in the NDC Directory. The product was first marketed by Viiv Healthcare Company on July 02, 2020 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 49702-250-18?

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 49702-250-18?

The 11-digit format is 49702025018. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-249702-250-185-4-249702-0250-18