Jesduvroq Tablet, Film Coated
NDC Package 0173-0897-13

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

Package Information

Jesduvroq (daprodustat) tablets is jESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.Limitations of UseJESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being.JESDUVROQ is not indicated for use:•As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.•For treatment of anemia of chronic kidney disease in patients who are not on dialysis. This formulation utilizes a tablet, film coated delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0897 and is authorized under FDA application NDA216951.

Identification & Billing

NDC Package Code
0173-0897-13
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0173-0897
11-Digit Billing Format
00173089713
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
Jesduvroq
Non-Proprietary Name
Daprodustat
Substance Name
Daprodustat
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)
DAPRODUSTAT 1 mg/1
Pharmacologic Class
Usage Information
JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.Limitations of UseJESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being.JESDUVROQ is not indicated for use:•As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.•For treatment of anemia of chronic kidney disease in patients who are not on dialysis.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA216951
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2023
End Marketing Date
01-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0173-0897). Click a package code to view its specific billing and regulatory data.

0173-0897-56
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

* 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 0173-0897-13 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Jesduvroq, a human prescription drug labeled by Glaxosmithkline Llc. 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 daprodustat 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 Glaxosmithkline Llc on February 01, 2023.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173089713. 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 (4-4-2)
0173-0897-13
11-Digit CMS (5-4-2)
00173-0897-13

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