Quick answers
- What is Mycophenilic acid used for?
- The FDA-approved label (Mycophenolic Acid, Archis Pharma LLC, December 29, 2025) says: “Mycophenolic acid delayed-release tablets are 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 Mycophenilic acid have a boxed warning?
- Yes. The FDA label for Mycophenolic Acid has a boxed warning (“WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS 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 Mycophenilic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mycophenilic acid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mycophenilic acid?
- 1 company lists prescription products of Mycophenilic acid in the FDA NDC Directory, including Archis Pharma LLC.
What Mycophenilic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Mycophenolic acid delayed-release tablets are 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: Mycophenolic Acid, Archis Pharma LLC, effective December 29, 2025. Read the full label on DailyMed →
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 WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
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 |
|---|---|---|
| mycophenolic acid 180 mg tablet, delayed release | Generic | $0.1022 per tablet |
| mycophenolic acid 360 mg tablet, delayed release | Generic | $0.2164 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Archis Pharma LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA091248Rk Pharma · January 8, 2014
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 485020, 485023 |
|---|---|
| SPL set ID of the quoted label | 30cb1078-929b-4c0f-be1d-49ef352dfab9 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | MYCOPHENOLIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mycophenolic Acid, Archis Pharma LLC, effective December 29, 2025; 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 →