Afinitor Tablet
NDC Package 0078-0620-51

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

Package Information

Afinitor (everolimus) tablets is everolimus is used to treat various types of cancer (such as kidney, breast, pancreas, lung, stomach/intestinal cancers). This formulation utilizes a tablet delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0620 and is authorized under FDA application NDA022334.

Identification & Billing

NDC Package Code
0078-0620-51
Package Description
28 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (0078-0620-61)
Product Code
0078-0620
11-Digit Billing Format
00078062051
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Afinitor
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 7.5 mg/1
Pharmacologic Class
Usage Information
Everolimus is used to treat various types of cancer (such as kidney, breast, pancreas, lung, stomach/intestinal cancers). Everolimus is also used in people with a certain genetic disorder (tuberous sclerosis complex) to treat certain types of benign tumors in the brain or kidney. It works by slowing or stopping the growth of cancer or tumor cells.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA022334
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-29-2011
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 0078-0620-51 identifies a specific commercial package of 28 blister pack in 1 carton / 1 tablet in 1 blister pack (0078-0620-61) of Afinitor, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 July 29, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Everolimus is used to treat various types of cancer (such as kidney, breast, pancreas, lung, stomach/intestinal cancers). Everolimus is also used in people with a certain genetic disorder (tuberous sclerosis complex) to treat certain types of benign tumors in the brain or kidney. It works by slowing or stopping the growth of cancer or tumor cells.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078062051. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
0078-0620-51
11-Digit CMS (5-4-2)
00078-0620-51

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