Zortress Tablet
NDC Package 0078-0422-20

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

Package Information

Zortress (everolimus) tablets is everolimus is used with other medications (such as cyclosporine) to prevent rejection of a kidney transplant. This formulation utilizes a tablet delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0422 and is authorized under FDA application NDA021560.

Identification & Billing

NDC Package Code
0078-0422-20
Package Description
60 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (0078-0422-61)
Product Code
0078-0422
11-Digit Billing Format
00078042220
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zortress
Non-Proprietary Name
Everolimus
Substance Name
Everolimus
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EVEROLIMUS 1 mg/1
Pharmacologic Class
Usage Information
Everolimus is used with other medications (such as cyclosporine) to prevent rejection of a kidney transplant. Everolimus is also used with other medications (such as tacrolimus) to prevent rejection of a liver transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA021560
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-22-2010
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7527
Source: ASP
Oral everolimus
HCPCS Dosage 0.25 MG
Units / Pkg 240

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0078-0422-20 identifies a specific commercial package of 60 blister pack in 1 box / 1 tablet in 1 blister pack (0078-0422-61) of Zortress, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet is formulated for oral use and contains everolimus 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 22, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Everolimus is used with other medications (such as cyclosporine) to prevent rejection of a kidney transplant. Everolimus is also used with other medications (such as tacrolimus) to prevent rejection of a liver transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078042220. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
0078-0422-20
11-Digit CMS (5-4-2)
00078-0422-20

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