Mycophenolate Mofetil Powder, For Suspension
NDC Package 64380-899-00

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

Package Information

Mycophenolate Mofetil powders 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 powder, for suspension delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-899 and is authorized under FDA application ANDA212634.

Identification & Billing

NDC Package Code
64380-899-00
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 225 mL in 1 BOTTLE, PLASTIC
Product Code
64380-899
11-Digit Billing Format
64380089900

Clinical Specifications

Proprietary Name
Mycophenolate Mofetil
Non-Proprietary Name
Mycophenolate Mofetil
Substance Name
Mycophenolate Mofetil
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MYCOPHENOLATE MOFETIL 200 mg/mL
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
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212634
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2026
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 64380-899-00 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 225 ml in 1 bottle, plastic of Mycophenolate Mofetil, a human prescription drug labeled by Strides Pharma Science Limited. This powder, for suspension 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 Strides Pharma Science Limited on September 01, 2026. The current certification is valid through December 31, 2027.

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 Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380089900. 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 (5-3-2)
64380-899-00
11-Digit CMS (5-4-2)
64380-0899-00

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