Mycophenolate Mofetil Capsule
NDC Package 68254-5000-2

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

Mycophenolate Mofetil capsules 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). This formulation utilizes a capsule delivery system. Marketed by Concord Biotech Limited, this product is identified by NDC 68254-5000 and is authorized under FDA application ANDA210181.

Identification & Billing

NDC Package Code
68254-5000-2
Package Description
500 CAPSULE in 1 BOTTLE
Product Code
68254-5000
11-Digit Billing Format
68254500002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mycophenolate Mofetil
Non-Proprietary Name
Mycophenolate Mofetil
Substance Name
Mycophenolate Mofetil
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MYCOPHENOLATE MOFETIL 250 mg/1
Pharmacologic Class
Antimetabolite Immunosuppressant - [EPC] (Established Pharmacologic Class)
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
Concord Biotech Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210181
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2019
Listing Expiration
12-31-2026
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 (68254-5000). Click a package code to view its specific billing and regulatory data.

68254-5000-1
100 CAPSULE in 1 BOTTLE

* 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 68254-5000-2 identifies a specific commercial package of 500 capsule in 1 bottle of Mycophenolate Mofetil, a human prescription drug labeled by Concord Biotech Limited. This capsule is formulated for oral use and contains mycophenolate mofetil 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 Concord Biotech Limited on October 01, 2019. The current certification is valid through December 31, 2026.

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 Concord Biotech Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68254500002. 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)
68254-5000-2
11-Digit CMS (5-4-2)
68254-5000-02

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