Mycophenolate Mofetil
Mycophenolate mofetil is an immunosuppressant (a medicine that dampens the immune system) used with other medicines to help prevent rejection of donated kidney, heart or liver transplants.
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 44 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Mycophenolate mofetil (CellCept), an immune-dampening medicine available as a generic and on the market since about 1995, is a mainstay alongside other anti-rejection drugs for kidney, heart and liver transplants; your body turns it into mycophenolic acid, which blocks an enzyme immune cells need to make DNA and multiply. Stomach and bowel upset, especially diarrhea, is what most people notice, and it can lower white and red blood cell counts, so keep up with blood tests. Its boxed warning covers pregnancy loss and birth defects, lymphoma and skin cancer, and serious infections, so report any fever promptly and plan pregnancy only with your transplant team.
Clinical pearls
- Take magnesium or aluminum antacids and sevelamer at least 2 hours after your dose, since they lower mycophenolate levels.
- It can weaken combination birth control pills, so add a barrier method and keep using contraception 6 weeks after stopping.
- Men should use effective contraception during treatment and for at least 90 days after, and should not donate sperm then.
- Do not swap it for mycophenolic acid delayed-release tablets on your own; the two are not interchangeable without supervision.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Mycophenolate mofetil can cause pregnancy loss and birth defects. Use in pregnancy raises the risk of first-trimester miscarriage and of malformations, including problems of the face and ears, limbs, heart, esophagus, kidney and nervous system. Women who could become pregnant must be counseled on preventing and planning pregnancy. It should be avoided in pregnancy if safer treatment options exist.
It also raises the risk of lymphoma and other cancers, especially of the skin. It increases the risk of bacterial, viral, fungal and protozoal infections, including reactivation of hepatitis B and C. These infections can lead to hospitalization or death. Watch for fever, new skin changes, swollen glands or any signs of infection, and call your doctor promptly.
Patient Information Guide A plain-language walkthrough of Mycophenolate Mofetil, written from its FDA label.
What Mycophenolate Mofetil Is Used For
▾
Mycophenolate mofetil is used to prevent organ rejection after a transplant.
- Kidney transplants (allogeneic, meaning from a donor), in adults and children 3 months and older
- Heart transplants, in adults and children 3 months and older
- Liver transplants, in adults and children 3 months and older
- Always in combination with other immunosuppressants
- CellCept, Myhibbin (oral suspension) and generic mycophenolate mofetil capsules, tablets, oral suspension and IV injection are all labeled for this use
How Mycophenolate Mofetil Works
▾
After you take it, your body converts mycophenolate mofetil to mycophenolic acid. This blocks an enzyme (IMPDH) that lymphocytes need to build DNA. Without it, these immune cells multiply less and respond less strongly to foreign tissue, so they are less likely to attack the transplanted organ.
The effect is cytostatic (slows cell growth) and reversible.
Mycophenolate Mofetil Dosage
▾
Mycophenolate mofetil is generally taken twice a day. Oral forms include capsules, tablets and oral suspension, and an IV form is given over at least 2 hours.
- CellCept Intravenous and generic injection are an alternative when someone can't take oral medicine, starting within 24 hours after transplant for up to 14 days.
- Food did not change total absorption but lowered the peak level.
- Children's doses are based on body size.
- Your doctor may lower or pause the dose if your white blood cell count drops.
Follow your prescriber and label directions.
Dosing details from the FDA-approved label
From the Mycophenolate Mofetil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adult Kidney Transplant
- 1 g twice daily, orally or intravenously (IV) over no less than 2 h (total daily dose of 2 g)
- Adult Heart Transplant
- 1.5 g twice daily orally or IV, over no less than 2 h
- Adult Liver Transplant
- 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 h
- Pediatric Kidney Transplant (3 months and older)
- 600 mg/m2 orally twice daily (oral suspension)
- Patients with BSA ≥ 1.25 m2 may be dosed with capsules or tablets per Table 1
- Maximum: maximum total daily dose of 2 g or 10 mL of the oral suspension
- Pediatric dosing is based on body surface area (BSA)
- Pediatric Heart Transplant
- 600 mg/m2 orally twice daily (starting dose)
- Maximum: up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension)
- Pediatric Liver Transplant
- 600 mg/m2 orally twice daily (starting dose)
- Maximum: up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally or intravenously (IV) over no less than 2 h (2.2) Heart Transplant 1.5 g twice daily orally or IV, over no less than 2 h (2.3) Liver Transplant 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 h (2.4) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily (2.2) Heart Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.4 ) CellCept intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. (2.1) Reduce or interrupt dosing in the event of neutropenia. (2.5) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ), preparation of oral suspension. (2.6) 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil for O ral Suspension Mycophenolate mofetil oral dosage forms (capsules, tablets or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil for oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water. The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary [see Clinical Pharmacology ( 12.3 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mycophenolate Mofetil Side Effects
▾
The most common side effects in clinical trials were:
Common side effects
- Diarrhea
- Vomiting
- Nausea
- Low white blood cell count (leukopenia)
- Infections
- Anemia (low red blood cells)
- High blood pressure
- Abdominal pain
When to get medical help
- Call your doctor right away for signs of infection, such as fever, chills or feeling unwell, because serious infections can lead to hospitalization or death.
- Get help for new or unusual neurological symptoms like confusion, weakness on one side, or loss of coordination, which can signal a rare brain infection (PML).
- Tell your doctor about unusual skin changes or swollen glands, since lymphoma and skin cancers are possible.
- Seek urgent care for signs of an allergic reaction, including trouble breathing or swelling.
- Report severe stomach pain, black or bloody stools, or vomiting blood, as bleeding, ulcers or perforations can occur.
- Tell your doctor about unusual bruising, bleeding or tiredness, which may point to low blood cell counts.
- Tell your doctor right away if you become pregnant.
Mycophenolate Mofetil Warnings and Precautions
▾
- Pregnancy: raises the risk of first-trimester pregnancy loss and birth defects.
- Cancers: higher risk of lymphoma and skin cancer, so limit sun exposure.
- Infections: serious bacterial, viral, fungal and protozoal infections, including BK virus kidney problems, CMV, PML and hepatitis B or C reactivation.
- Blood problems: low neutrophils and pure red cell aplasia need blood monitoring.
- Stomach and bowel: bleeding, ulcers and perforations are possible.
- Avoid live vaccines. Don't donate blood for 6 weeks after treatment or semen for 90 days after.
Mycophenolate Mofetil Interactions
▾
Several medicines can change mycophenolate levels or be affected by it.
- Magnesium or aluminum antacids and sevelamer: take at least 2 hours after mycophenolate, since they lower levels.
- Proton pump inhibitors (lansoprazole, pantoprazole): may lower levels and reduce effectiveness.
- Cyclosporine, cholestyramine, rifampin, trimethoprim/sulfamethoxazole and some antibiotics: can lower levels.
- Telmisartan and isavuconazole: change levels by affecting how the drug is processed.
- Acyclovir, valacyclovir, ganciclovir, valganciclovir and probenecid: levels may rise.
- Combination birth control pills: may work less well, so add a barrier method.
Interactions listed in the FDA-approved label
From the Mycophenolate Mofetil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Antacids with magnesium or aluminum hydroxide: Decreases MPA systemic exposure, which may reduce mycophenolate mofetil efficacy. Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration.
- Proton pump inhibitors (e.g., lansoprazole, pantoprazole): Decreases MPA systemic exposure, which may reduce mycophenolate mofetil efficacy. Monitor patients for alterations in efficacy when PPIs are co-administered with mycophenolate mofetil.
- Drugs that interfere with enterohepatic recirculation (e.g., cyclosporine A, trimethoprim/sulfamethoxazole, cholestyramine, rifampin, aminoglycoside, cephalosporin, fluoroquinolone and penicillin antimicrobials): Can decrease MPA systemic exposure, which may reduce mycophenolate mofetil efficacy. Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered.
- Drugs modulating glucuronidation (telmisartan induces; isavuconazole inhibits): Inducers decrease MPA systemic exposure, potentially reducing efficacy; inhibitors increase MPA systemic exposure, which may increase the risk of adverse reactions. Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered.
- Calcium free phosphate binders (e.g., sevelamer): Decrease MPA systemic exposure, which may reduce mycophenolate mofetil efficacy. Administer calcium free phosphate binders at least 2 hours after mycophenolate mofetil.
- Drugs that undergo renal tubular secretion (e.g., acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir): Metabolite MPAG may compete with these drugs, which may increase plasma concentrations and/or adverse reactions associated with them. Monitor for drug-related adverse reactions in patients with renal impairment.
- Combination oral contraceptives: Decreased systemic exposure to levonorgestrel but did not affect ethinylestradiol exposure, which may result in reduced contraceptive effectiveness. Use additional barrier contraceptive methods.
Read the label’s full interactions text
7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. (7.1) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. (7.2) See FPI for other important drug interactions. (7) 7.1 Effect of Other Drugs on Mycophenolate Mofetil Table 7 Drug Interactions with Mycophenolate Mofetil that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration. Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with mycophenolate mofetil. Examples Lansoprazole, pantoprazole Drugs that Interfere with Enterohepatic Recirculation Clinical Impact Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before Taking Mycophenolate Mofetil
▾
- Do not use if allergic to mycophenolate mofetil, mycophenolic acid or any ingredient.
- The injection is not for people allergic to Polysorbate 80.
- Pregnancy tests are needed before starting and again 8 to 10 days later for women who could become pregnant.
- Women should use acceptable contraception during treatment and for 6 weeks after.
- Men and their partners should use effective contraception during treatment and for at least 90 days after.
- Breastfeeding: risks to the infant can't be ruled out.
- Children 3 months and older have established safety and effectiveness.
- Older adults: dosing should consider kidney, liver and heart function.
- Avoid if you have hypoxanthine-guanine phosphoribosyl-transferase deficiency.
- The oral suspension contains aspartame (phenylketonuria).
Mycophenolate Mofetil Overdose
▾
An overdose may cause low white blood cells (leukopenia, neutropenia) and stomach symptoms like abdominal pain, diarrhea, nausea, vomiting and indigestion. Dialysis usually doesn't remove the drug, but bile acid sequestrants such as cholestyramine can help remove it. Get medical help right away if you think too much was taken.
How Your Body Processes Mycophenolate Mofetil
▾
Mycophenolate mofetil is fully converted to its active form, mycophenolic acid, after oral or IV dosing. About 94% of the oral dose is absorbed compared with IV. Food lowers the peak blood level by about 40% but doesn't change total absorption. Mycophenolic acid is 97% bound to albumin in the blood. Blood levels are lower in the first weeks after transplant than later.
How to Store Mycophenolate Mofetil
▾
and Dispensing Information: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers. Store dry powder at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Mycophenolate Mofetil: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Mycophenolate Mofetil — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
▾
How should I take it?
▾
What side effects are normal, and when should I call?
▾
Can I take antacids or other medicines with it?
▾
What about pregnancy and birth control?
▾
Do I need to take any other precautions?
▾
Is Mycophenolate Mofetil available over the counter?
▾
When was Mycophenolate Mofetil first available?
▾
Who makes Mycophenolate Mofetil?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Mycophenolate Mofetil on HelloPharmacist
Mycophenolate Mofetil Forms and Strengths (How It Comes)
Mycophenolate Mofetil is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Mycophenolate Mofetil inactive ingredients by manufacturer.
Tablet
How this form is used
- Mycophenolate mofetil tablets are used to prevent rejection of kidney, heart or liver transplants, with other immunosuppressants.
- Mycophenolate mofetil tablets are taken by mouth, generally twice daily.
- Mycophenolate mofetil tablets should be used under the supervision of a physician experienced in immunosuppressive therapy.
- Mycophenolate mofetil tablets should not be swapped with mycophenolic acid delayed-release tablets without supervision.
Capsule
How this form is used
- Mycophenolate mofetil capsules are used to prevent rejection of kidney, heart or liver transplants, with other immunosuppressants.
- Mycophenolate mofetil capsules are taken by mouth, generally twice daily.
- Mycophenolate mofetil capsules should not be swapped with mycophenolic acid delayed-release tablets without physician supervision.
Oral suspension
How this form is used
- Myhibbin oral suspension is used to prevent rejection of kidney, heart or liver transplants, with other immunosuppressants.
- Mycophenolate mofetil for oral suspension is used for the same transplant types in adults and children 3 months and older.
- Myhibbin is taken by mouth, generally twice daily, under the supervision of a physician experienced in immunosuppressive therapy.
- Myhibbin should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision.
- The oral suspension contains aspartame, which matters for people with phenylketonuria.
Injection
How this form is used
- Mycophenolate Mofetil for Injection is used to prevent rejection of kidney, heart or liver transplants, with other immunosuppressants.
- Mycophenolate Mofetil for Injection is given into a vein, over no less than 2 hours.
- CellCept Intravenous is an alternative when patients cannot tolerate oral medication.
- CellCept Intravenous is started within 24 hours after transplantation and used until the patient can take oral medicine, for up to 14 days.
- Mycophenolate Mofetil for Injection should not be used by people allergic to Polysorbate 80.
Mycophenolate Mofetil on the U.S. Market: Products, Makers and Brands
How Mycophenolate Mofetil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
37 companies list 63 Mycophenolate Mofetil product records with the FDA, mostly as tablet, capsule, oral suspension; the earliest marketing or approval year on record is 1995. Brand names on the directory include CellCept, Myhibbin; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (22) · Unfinished injection (1) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How Widely Mycophenolate Mofetil Is Used (Medicaid Data)
A general measure of how commonly Mycophenolate Mofetil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Mycophenolate Mofetil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Mycophenolate Mofetil prescribed? Of the 1,603 medications we measure, Mycophenolate Mofetil ranks #329 by Medicaid prescriptions — more than 79% of them.
Utilization by Mycophenolate Mofetil product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
mycophenolate mofetil 500 MG Oral Tablet Most dispensed
Summed across the 21 of 79 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200060
mycophenolate mofetil 250 MG Oral Capsule
Summed across the 24 of 66 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199058
mycophenolate mofetil 200 MG/ML Oral Suspension
Summed across the 8 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311880
mycophenolate mofetil 500 MG Injection
Summed across the 1 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311881
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mycophenolate Mofetil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 54 of 174 listed Mycophenolate Mofetil NDCs with Medicaid activity.
Compare Mycophenolate Mofetil Products
A representative set of FDA-listed product records for Mycophenolate Mofetil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 250 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 250 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 250 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 250 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 250 mg | Oral | AvKARE | ANDA | View NDC → |
| 250 mg | Oral | AvPAK | ANDA | View NDC → |
| 250 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 250 mg | Oral | Concord Biotech Limited | ANDA | View NDC → |
| 250 mg | Oral | Genentech, Inc. | NDA | View NDC → |
| 250 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 250 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Sandoz Inc | ANDA | View NDC → |
| 250 mg | Oral | Strides Pharma Inc. | ANDA | View NDC → |
| 250 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 250 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Wuxi Fortune Pharmaceutical Co.,Ltd. | ANDA | View NDC → |
| 💊Injection | ||||
| 500 mg/20 mL | Intravenous | Armas Pharmaceuticals Inc | ANDA | View NDC → |
| 500 mg/20 mL | Intravenous | BPI Labs LLC | ANDA | View NDC → |
| 500 mg/20 mL | Intravenous | Genentech, Inc. | NDA | View NDC → |
| 500 mg/20 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg/20 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 500 mg/20 mL | Intravenous | Onesource Specialty Pharma Limited | ANDA | View NDC → |
| 500 mg/20 mL | Intravenous | Par Health USA, LLC | ANDA | View NDC → |
| 💊Oral suspension | ||||
| 200 mg/mL | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 200 mg/mL | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 200 mg/mL | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 200 mg/mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg/mL | Oral | Azurity Pharmaceuticals, Inc. | NDA | View NDC → |
| 200 mg/mL | Oral | Genentech, Inc. | NDA | View NDC → |
| 200 mg/mL | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg/mL | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 200 mg/mL | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 200 mg/mL | Oral | Quagen Pharmaceuticals Llc | ANDA | View NDC → |
| 200 mg/mL | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 200 mg/mL | Oral | VistaPharm, LLC | ANDA | View NDC → |
| 💊Tablet | ||||
| 500 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 500 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 500 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 500 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 500 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | AvKARE | ANDA | View NDC → |
| 500 mg | Oral | AvPAK | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 500 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 500 mg | Oral | Concord Biotech Limited | ANDA | View NDC → |
| 500 mg | Oral | Genentech, Inc. | NDA | View NDC → |
| 500 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 500 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 500 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 500 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Sandoz Inc | ANDA | View NDC → |
| 500 mg | Oral | Strides Pharma Inc. | ANDA | View NDC → |
| 500 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
Showing 63 of 63 products — FDA National Drug Code Directory. See every product, package size and price: browse all 63 Mycophenolate Mofetil NDCs →
Mycophenolate Mofetil Side Effects Reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mycophenolate Mofetil — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Mycophenolate Mofetil are diarrhoea, pyrexia, pneumonia; about 91% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mycophenolate Mofetil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Mycophenolate Mofetil FDA Approval History
How Mycophenolate Mofetil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Mycophenolate Mofetil was first approved by the FDA in 1995 (Brand: CELLCEPT · Roche Palo); the first generic version was approved in 2008. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Mycophenolate Mofetil Recall History
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Mycophenolate Mofetil recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- 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 67457-3… Lots: Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027 FDA record D-0830-2026 →
- 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… Lots: Lot #: 3241653, Exp 4/30/2027 FDA record D-0734-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 68149 4 dose forms · 4 strengths
-
Dose form (SCDF) Injection RxCUI 1726176In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 311881 -
Dose form (SCDF) Oral Capsule RxCUI 379060In current FDA listingsClinical drug / strength (SCD) 250 MGRxCUI 199058 -
Dose form (SCDF) Oral Suspension RxCUI 374670In current FDA listingsClinical drug / strength (SCD) 200 MG/MLRxCUI 311880 -
Dose form (SCDF) Oral Tablet RxCUI 374667In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 200060
Look up RxCUI 68149 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Mycophenolate Mofetil Supply and Shortage Status
Whether Mycophenolate Mofetil is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Mycophenolate Mofetil Costs Pharmacies (NADAC Benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Oct 7, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 250 mg | $8.65 per capsule | NDC details & price history |
| Tablet, Film Coated · Oral | 500 mg | $17.34 per tablet | NDC details & price history |
| Powder, For Suspension · Oral | 200 mg/mL | $8.31 per mL | NDC details & price history |
| Tablet · Oral | 500 mg | $0.263 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Mycophenolate Mofetil Brand Names
Mycophenolate Mofetil is sold under 2 brand names in the FDA directory — CellCept, Myhibbin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Mycophenolate Mofetil: Manufacturers and Labelers
37 companies list Mycophenolate Mofetil products with the FDA. By number of product records, the largest are Genentech, Inc., Remedyrepack Inc., Ascend Laboratories, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 13 more on the FDA NDC directory.
Sources for This Mycophenolate Mofetil Page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →