Cellcept
NDC Package 12806-0259-4

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cellcept is mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). Marketed by F. Hoffmann-la Roche Ltd, this product is identified by NDC 12806-0259 and is authorized under FDA application NDA050722.

Identification & Billing

NDC Package Code
12806-0259-4
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 500 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
12806-0259
11-Digit Billing Format
12806025904

Clinical Specifications

Proprietary Name
Cellcept
Dosage Form
-
Usage Information
Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called 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
F. Hoffmann-la Roche Ltd
FDA Application #
NDA050722
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-03-1995
End Marketing Date
06-20-2010
Listing Expiration
06-20-2010
Exclude Flag
D
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 (12806-0259). Click a package code to view its specific billing and regulatory data.

12806-0259-1
1 BOTTLE, PLASTIC in 1 CARTON / 100 CAPSULE in 1 BOTTLE, PLASTIC
12806-0259-5
12 BOTTLE, PLASTIC in 1 CARTON / 120 CAPSULE in 1 BOTTLE, PLASTIC

* 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 12806-0259-4 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 500 capsule in 1 bottle, plastic of Cellcept, labeled by F. Hoffmann-la Roche Ltd. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by F. Hoffmann-la Roche Ltd on May 03, 1995. The current certification is valid through June 20, 2010.

What are the primary indications for this medication?

Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called 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 F. Hoffmann-la Roche Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12806025904. 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 (5-4-1)
12806-0259-4
11-Digit CMS (5-4-2)
12806-0259-04

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