Mycophenolic Acid
NDC Package 70518-3255-0

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

Package Information

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

Mycophenolic Acid is mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted kidney. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-3255 and is authorized under FDA application ANDA091558.

Identification & Billing

NDC Package Code
70518-3255-0
Package Description
120 POUCH in 1 BOX / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3255-1)
Product Code
70518-3255
11-Digit Billing Format
70518325500

Clinical Specifications

Proprietary Name
Mycophenolic Acid
Dosage Form
-
Usage Information
Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted kidney. 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 kidney as if it were your own.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA091558
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2021
End Marketing Date
11-22-2021
Listing Expiration
11-22-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-3255-0 identifies a specific commercial package of 120 pouch in 1 box / 1 tablet, delayed release in 1 pouch (70518-3255-1) of Mycophenolic Acid, labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on October 23, 2021. The current certification is valid through November 22, 2021.

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 kidney. 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 kidney as if it were your own.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518325500. 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)
70518-3255-0
11-Digit CMS (5-4-2)
70518-3255-00

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