Quick answers
- What is Mycophenolic acid used for?
- The FDA-approved label (Myfortic, Novartis Pharmaceuticals Corporation, July 29, 2026) says: “Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mycophenolic acid have a boxed warning?
- Yes. The FDA label for Myfortic has a boxed warning (“WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mycophenolic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mycophenolic acid been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 3, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Mycophenolic acid?
- 16 companies list prescription products of Mycophenolic acid in the FDA NDC Directory, including Biocon Pharma Inc., Ascend Laboratories, LLC and Major Pharmaceuticals.
What Mycophenolic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use …
— FDA label: Myfortic, Novartis Pharmaceuticals Corporation, effective July 29, 2026. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
. Read it on the full label →
15 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 35 in the FDA NDC Directory |
| Brand names | Myfortic |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| mycophenolate sodium 180 mg tablet, delayed release | Generic | $0.1022 per tablet |
| mycophenolate sodium 180 mg tablet, delayed release | Brand: Myfortic | $7.43 per tablet |
| mycophenolate sodium 360 mg tablet, delayed release | Generic | $0.2164 per tablet |
| mycophenolate sodium 360 mg tablet, delayed release | Brand: Myfortic | $14.93 per tablet |
NADAC list of November 4, 2026; these prices took effect between July 8, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Biocon Pharma Inc.4 products
- Ascend Laboratories, LLC4 products
- Major Pharmaceuticals3 products
- American Health Packaging2 products
- Advagen Pharma Limited2 products
- Accord Healthcare Inc.2 products
- Aurobindo Pharma Limited2 products
- Novugen Pharma (USA) LLC2 products
- Stellon Biotech Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Slate Run Pharmaceuticals, LLC2 products
- Novartis Pharmaceuticals Corporation2 products
- Concord Biotech Limited2 products
- Apotex Corp.2 products
- A-S Medication Solutions1 product
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050791 MYFORTIC | Novartis | February 27, 2004 | 28, latest July 29, 2026 2026: REMS · 2026: Labeling · 2025: Labeling |
Generic approvals (9)
- ANDA091558Apotex Inc · August 21, 2012
- ANDA202555Accord Hlthcare · August 23, 2017
- ANDA211173Concord Biotech Ltd · December 13, 2019
- ANDA214376Yichang Humanwell · February 10, 2021
- ANDA208315Alkem Labs Ltd · September 23, 2021
- ANDA214630Biocon Pharma · November 29, 2021
- ANDA217031Biocon Pharma · November 29, 2023
- ANDA218603Aurobindo Pharma Ltd · February 27, 2024
- ANDA216637Fosun Wanbang · May 29, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 3, 2024 · Class II · Ongoing · D-0668-2024
Failed Dissolution Specifications
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12. — Ascend Laboratories, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 485020, 485023, 616449, 616450 |
|---|---|
| SPL set ID of the quoted label | eed26501-890d-4ff6-88e7-6dbea4726e53 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA050791, 9 ANDA |
| Active ingredients (FDA) | MYCOPHENOLATE SODIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Myfortic, Novartis Pharmaceuticals Corporation, effective July 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →