Vanrafia Tablet, Film Coated
NDC Package 0078-1420-15

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

Package Information

Vanrafia (atrasentan) tablets is vANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1420 and is authorized under FDA application NDA219208.

Identification & Billing

NDC Package Code
0078-1420-15
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0078-1420
11-Digit Billing Format
00078142015
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
Vanrafia
Non-Proprietary Name
Atrasentan
Substance Name
Atrasentan Hydrochloride
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)
ATRASENTAN HYDROCHLORIDE .75 mg/1
Pharmacologic Class
Usage Information
VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)]. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA219208
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-02-2025
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 0078-1420-15 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Vanrafia, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. 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 atrasentan hydrochloride 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 Novartis Pharmaceuticals Corporation on April 02, 2025. The current certification is valid through December 31, 2027.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078142015. 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)
0078-1420-15
11-Digit CMS (5-4-2)
00078-1420-15

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