Mycophenolate
Mycophenolate (mycophenolate mofetil) is an immune-suppressing medicine used with other medicines to help prevent rejection of a transplanted kidney, heart or liver.
🧬 Where this information comes from Click to expand
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 is an immune-suppressing medicine taken with other anti-rejection drugs to protect a transplanted kidney, heart or liver. It is a standard part of most transplant regimens and is available as a generic, and it works by blocking an enzyme that immune cells (lymphocytes) need to make DNA, so they multiply less. Stomach upset is what most people notice, mainly diarrhea, nausea and vomiting, and it can lower blood counts, so regular blood tests are part of treatment. Its boxed warning covers pregnancy loss and serious birth defects, lymphoma and skin cancer, and serious infections, so strict pregnancy prevention, daily sun protection and prompt calls about fever or new skin changes all matter.
Clinical pearls
- Take magnesium or aluminum antacids, and calcium-free phosphate binders like sevelamer, at least 2 hours after mycophenolate.
- Birth control pills may work less well with mycophenolate, so add a barrier method such as condoms.
- If a refill looks different, check it was not switched to mycophenolic acid delayed-release tablets, which are not a direct swap.
- Do not donate blood during treatment or for 6 weeks after, and men should not donate semen until 90 days after.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Mycophenolate can cause pregnancy loss and serious birth defects, so avoid it in pregnancy if safer options exist. Females who could become pregnant need counseling about preventing and planning pregnancy.
It also raises the risk of lymphoma and other cancers, particularly skin cancer. In addition, it makes you more prone to bacterial, viral, fungal and protozoal infections, including opportunistic infections and reactivation of hepatitis B and C. These infections can lead to hospitalization or death. Watch for fever, signs of infection and new skin changes, and call your doctor promptly.
Patient information guide A plain-language walkthrough of Mycophenolate, written from its FDA label.
What Mycophenolate is used for
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Mycophenolate is used to prevent organ rejection, always alongside other immunosuppressants.
- Kidney transplant, in adults and children 3 months and older
- Heart transplant, in adults and children 3 months and older
- Liver transplant, in adults and children 3 months and older
- This applies to CellCept, Myhibbin and generic mycophenolate mofetil products. Injection is for intravenous use and oral forms are taken by mouth.
How Mycophenolate works
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Mycophenolate is converted in the body to mycophenolic acid. This blocks an enzyme (IMPDH) that lymphocytes need to build DNA and multiply. As a result, T and B immune cells grow less and respond less to the transplanted organ.
The effect slows these cells rather than destroying them, and it is reversible.
Mycophenolate dosage
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Mycophenolate is generally taken twice a day by mouth, or given by IV over at least 2 hours when oral use isn't possible. Food did not change total absorption but lowered the peak level. Your prescriber may reduce or pause doses if your white blood cell count drops. Follow your prescriber and label for dosing and any missed doses.
Dosing details from the FDA-approved label
From the Mycophenolate 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.
- Adults: Kidney Transplant
- 1 g twice daily, orally or intravenously (IV) over no less than 2 h (total daily dose of 2 g)
- Take orally on an empty stomach; may be taken with food in stable transplant patients if necessary
- Adults: Heart Transplant
- 1.5 g twice daily orally or IV, over no less than 2 h
- Adults: Liver Transplant
- 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 h
- Pediatrics: Kidney Transplant
- 600 mg/m2 orally twice daily
- Maximum: 2 g daily (or 10 mL of the oral suspension)
- 3 months and older; dosing based on BSA; BSA ≥ 1.25 m2 may be dosed with capsules or tablets
- Pediatrics: Heart Transplant
- 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily
- Maximum: 900 mg/m2 twice daily (3 g or 15 mL of oral suspension)
- Pediatrics: Liver Transplant
- 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily
- Maximum: 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 side effects
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Common side effects in studies included:
Common side effects
- Diarrhea
- Vomiting
- Nausea
- Low white blood cell count (leukopenia)
- Infections
- Anemia (low red blood cells)
- High blood pressure
- Headache
- Headache, swelling and pain
When to get medical help
- Call your doctor right away for signs of infection such as fever, chills, cough or sore throat. Serious infections can lead to hospitalization or death.
- Get help for unusual bleeding, bruising, severe tiredness or paleness. These can signal blood count problems such as neutropenia or red cell aplasia.
- Tell your doctor about stomach pain, black or bloody stools, or vomiting blood, which can signal bleeding, ulcers or perforation.
- Report new neurological symptoms such as confusion, weakness on one side, or trouble with balance. These can signal a rare brain infection (PML).
- Report any new skin changes or lumps, since lymphoma and skin cancer risk is higher.
- Seek emergency help for signs of a serious allergic reaction.
- Tell your doctor right away if you become pregnant or suspect you are pregnant.
Mycophenolate warnings and precautions
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- Pregnancy: raises the risk of first trimester pregnancy loss and birth defects of the ears, face, limbs, heart, kidneys and nervous system.
- Cancer: higher risk of lymphoma and skin cancer, related to the intensity and length of immunosuppression.
- Infections: including BK virus kidney problems, PML, CMV and hepatitis B or C reactivation.
- Blood problems: neutropenia and pure red cell aplasia need blood monitoring.
- Stomach and intestines: bleeding, ulcers and perforation can occur.
- Acute inflammatory syndrome: a paradoxical inflammatory reaction to watch for.
Mycophenolate interactions
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Several medicines can change mycophenolate levels or be affected by it.
- Magnesium or aluminum antacids and sevelamer: lower absorption, so take them at least 2 hours after mycophenolate.
- Proton pump inhibitors: may lower levels and reduce effectiveness.
- Cholestyramine, rifampin, cyclosporine, trimethoprim/sulfamethoxazole and some antibiotics: can lower levels.
- Telmisartan and isavuconazole: change levels through glucuronidation.
- Acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid: levels may rise.
- Birth control pills: may be less effective, so add a barrier method.
- Live vaccines: avoid.
Interactions listed in the FDA-approved label
From the Mycophenolate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Antacids with magnesium or aluminum hydroxide: Decrease 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): Decrease MPA systemic exposure, which may reduce mycophenolate mofetil efficacy. Monitor patients for alterations in efficacy when PPIs are co-administered.
- Drugs that interfere with enterohepatic recirculation (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.
- Drugs modulating glucuronidation (telmisartan induces; isavuconazole inhibits): Inducers decrease MPA exposure, potentially reducing efficacy; inhibitors increase MPA exposure, which may increase the risk of adverse reactions. Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions.
- 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 (acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir): Metabolite MPAG may compete with these drugs, which may increase their plasma concentrations and/or adverse reactions. Monitor for drug-related adverse reactions in patients with renal impairment.
- Combination oral contraceptives: Decreased systemic exposure to levonorgestrel but did not affect ethinylestradiol, 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
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- Do not use if allergic to mycophenolate mofetil, mycophenolic acid or any ingredient.
- Injection: not for people allergic to Polysorbate 80.
- Avoid in HGPRT deficiency.
- Use caution with stomach or intestinal disorders.
- Females who could become pregnant need pregnancy tests and acceptable birth control during treatment and for 6 weeks after.
- Male patients and their partners should use effective contraception during treatment and for at least 90 days after.
- Breastfeeding data are limited, so discuss with your doctor.
- Older adults: dose selection should consider reduced organ function and other medicines.
Mycophenolate overdose
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Too much can cause low white blood cell counts, especially neutropenia, along with stomach pain, diarrhea, nausea, vomiting and indigestion. Higher doses were linked to more stomach intolerance and blood count changes. Dialysis usually does not remove it, but bile acid sequestrants such as cholestyramine can help remove mycophenolic acid.
How your body processes Mycophenolate
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After oral or IV dosing, mycophenolate mofetil is fully converted to its active form, mycophenolic acid. Oral absorption was about 94% of the IV amount in healthy volunteers. Food did not change total absorption but lowered the peak level by about 40%. Mycophenolic acid is 97% bound to albumin in the blood. Blood levels were lower in the early weeks after transplant than later.
How to store Mycophenolate
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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 →
Supplements & herbs that interact with Mycophenolate
17 supplements and herbal products have documented interactions with Mycophenolate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Mycophenolate: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mycophenolate — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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What side effects are common?
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Can I take antacids or other medicines with it?
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What about pregnancy?
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Do I need to protect myself from the sun?
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Is Mycophenolate available over the counter?
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When was Mycophenolate first available?
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Who makes Mycophenolate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Mycophenolate on HelloPharmacist
Mycophenolate forms and strengths (how it comes)
Mycophenolate 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 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 not be used interchangeably with mycophenolic acid delayed-release tablets.
Capsule
How this form is used
- Mycophenolate mofetil capsules are used to prevent rejection of kidney, heart or liver transplants, with other immunosuppressants.
- CellCept is used to prevent organ rejection in adults and children 3 months and older.
- Mycophenolate mofetil capsules are taken by mouth, generally twice daily.
- Mycophenolate mofetil capsules should not be used interchangeably with mycophenolic acid delayed-release tablets.
Oral suspension
How this form is used
- Myhibbin 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 twice daily under the supervision of a physician experienced in immunosuppressive therapy.
- 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, twice daily.
- Mycophenolate Mofetil for Injection is an alternative when oral medicine can't be tolerated, given within 24 hours after transplant for up to 14 days.
- Mycophenolate Mofetil for Injection should not be used in people allergic to Polysorbate 80.
Mycophenolate on the U.S. market: products, makers and brands
How Mycophenolate 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 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, Myfortic, Mycophenolate Mofetil and 1 more; 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 (36) — bulk drug substance sold to compounders/manufacturers 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 is used (Medicaid data)
A general measure of how commonly Mycophenolate 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 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 prescribed? Of the 1,601 medications we measure, Mycophenolate ranks #329 by Medicaid prescriptions — more than 79% of them.
Utilization by Mycophenolate 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.
Other Mycophenolate products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 54 of 183 listed NDC products with Medicaid activity.
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, 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 183 listed Mycophenolate NDCs with Medicaid activity.
Compare Mycophenolate products
A representative set of FDA-listed product records for Mycophenolate — 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 NDCs →
Mycophenolate 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 — a signal of what to watch for, not proof the drug caused it.
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 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 FDA approval history
How Mycophenolate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Mycophenolate 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 3 Mycophenolate recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. 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 →
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. Lots: Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025. FDA record D-0093-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Mycophenolate supply and shortage status
Whether Mycophenolate 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 costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 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 brand names
Mycophenolate is sold under 4 brand names in the FDA directory — CellCept, Myfortic, Mycophenolate Mofetil, Myhibbin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mycophenolate: manufacturers and labelers
37 companies list Mycophenolate 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 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 →