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Prescription medicine · generic available

Mycophenolate mofetil

Brand names: Cellcept, Myhibbin

Also listed by the FDA as: mycophenolate mofetil · mycophenolate mofetil hydrochloride

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
5Recalls (FDA reports)
39Companies
1995First FDA approval on file

Quick answers

What is Mycophenolate mofetil used for?
The FDA-approved label (CellCept, Genentech, Inc., August 5, 2026) says: “CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney […], heart […] or liver transplants […], in combination with other immunosuppressants. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Mycophenolate mofetil have a boxed warning?
Yes. The FDA label for CellCept has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Mycophenolate mofetil?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Mycophenolate mofetil been recalled?
FDA enforcement reports list 5 recalls of products of this medicine; the newest started August 26, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Mycophenolate mofetil?
39 companies list prescription products of Mycophenolate mofetil in the FDA NDC Directory, including Genentech, Inc., Remedyrepack Inc. and Strides Pharma Science Limited.

What Mycophenolate mofetil is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney […], heart […] or liver transplants […], in combination with other immunosuppressants. …

— FDA label: CellCept, Genentech, Inc., effective August 5, 2026. Read the full label on DailyMed →

The FDA has 41 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. Read it on the full label →

41 of 41 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Tablet, film coated · Powder, for suspension · Injection, powder, lyophilized, for solution · Tablet · Suspension
RouteOral · Intravenous
Prescription products64 in the FDA NDC Directory
Brand namesCellcept, Myhibbin

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.

NADAC per unit for Mycophenolate mofetil, by strength and form
Strength and formGeneric or brandPharmacies pay
mycophenolate mofetil 200 mg/mL
powder, for suspension		 Generic $0.9153 per mL
mycophenolate mofetil 200 mg/mL
powder, for suspension		 Brand: CellCept $8.31 per mL
mycophenolate mofetil 250 mg
capsule		 Generic $0.1347 per capsule
mycophenolate mofetil 250 mg
capsule		 Brand: CellCept $8.64 per capsule
mycophenolate mofetil 500 mg
tablet		 Generic $0.2530 per tablet
mycophenolate mofetil 500 mg
tablet, film coated		 Generic $0.2530 per tablet
mycophenolate mofetil 500 mg
tablet, film coated		 Brand: CellCept $17.36 per tablet

NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA050722
CELLCEPT		 Roche PaloMay 3, 1995 43, latest July 29, 2026
2026: REMS · 2026: Labeling · 2025: Labeling
NDA050723
CELLCEPT		 Roche PaloJune 19, 1997 42, latest July 29, 2026
2026: REMS · 2026: Labeling · 2025: Labeling
NDA050758
CELLCEPT		 Roche PaloAugust 12, 1998 41, latest July 29, 2026
2026: REMS · 2026: Labeling · 2025: Labeling
NDA050759
CELLCEPT		 Roche PaloOctober 1, 1998 45, latest July 29, 2026
2026: REMS · 2026: Labeling · 2025: Labeling
NDA216482
MYHIBBIN		 AzurityMay 1, 2024 4, latest July 29, 2026
2026: REMS · 2026: Labeling · 2025: Labeling

Generic approvals (30)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. August 26, 2026 · Class II · Ongoing · D-0830-2026

    Failed Dissolution Specifications

    Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: My — Mylan Pharmaceuticals Inc

  2. July 2, 2026 · Class II · Ongoing · D-0734-2026

    Presence of precipitate

    Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND — MYLAN PHARMACEUTICALS INC

  3. October 26, 2023 · Class III · Terminated · D-0093-2024

    Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

    Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. — VistaPharm LLC

  4. April 30, 2019 · Class I · Terminated · D-1293-2019

    Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

    Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044 — Par Pharmaceutical, Inc.

  5. September 27, 2012 · Class III · Terminated · D-097-2013

    Short Fill: some bottles contained less than 120-count per labeled claim.

    CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, I — Genentech, Inc.

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)199058, 200060, 213394, 311880, 311881, 616435, 616444, 616447
SPL set ID of the quoted label37241e87-4af4-4dc3-a1aa-ea6f20d8dc40
FDA labels (SPL)41
FDA applicationsNDA050722, NDA050723, NDA050758, NDA050759, NDA216482, 30 ANDA
Active ingredients (FDA)MYCOPHENOLATE MOFETIL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — CellCept, Genentech, Inc., effective August 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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