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Brand-name prescription medicine

CellCept

Generic name: Mycophenolate mofetil

FDA application holder: Roche Palo

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

Quick answers

What is CellCept?
CellCept is a brand name of Mycophenolate mofetil, a prescription medicine. The FDA NDC Directory lists 4 CellCept products in 4 strengths and forms.
Who makes CellCept?
Roche Palo holds the FDA application for CellCept (NDA050722, approved May 3, 1995).
Is there a generic or store brand of CellCept?
Yes. The FDA NDC Directory lists 49 other products with the same active ingredients, strength and form as a CellCept product, 49 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for CellCept?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 3 CellCept strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has CellCept been recalled?
FDA enforcement reports list 1 recall of CellCept products; the newest started September 27, 2012. A recall usually concerns specific lots, not every product.

What CellCept is

Each CellCept product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Mycophenolate mofetil · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
mycophenolate mofetil 200 mg/mL
powder, for suspension (oral)
CellCept 11 products, 11 companies DailyMed
mycophenolate mofetil 250 mg
capsule (oral)
CellCept 19 products, 18 companies DailyMed
mycophenolate mofetil 500 mg
tablet, film coated (oral)
CellCept 18 products, 17 companies DailyMed
mycophenolate mofetil hydrochloride 500 mg/20 mL
injection, powder, lyophilized, for solution (intravenous)
CellCept 1 product, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Mycophenolate mofetil →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of CellCept products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA050722Roche PaloMay 3, 19951
NDA050723Roche PaloJune 19, 19971
NDA050758Roche PaloAugust 12, 19981
NDA050759Roche PaloOctober 1, 19981

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

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of CellCept products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. 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.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, 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. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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