Eisai Inc.
NDC labeler code: 62856
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- PerampanelFycompa · 7 products
- LenvatinibLenvima · 5 products
- Donepezil hydrochlorideAricept · 3 products
- RufinamideBanzel · 3 products
- Lecanemab-irmbLecanemab Autoinjector · 2 products
- LecanemabLeqembi · 2 products
- LemborexantDayvigo · 2 products
- Eribulin mesylateHalaven · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 29, 2025 | BLA761375 | Lecanemab-irmb LEQEMBI IQLIK | Eisai Inc |
| January 6, 2023 | BLA761269 | Lecanemab LEQEMBI | Eisai Inc |
| December 20, 2019 | NDA212028 | Lemborexant DAYVIGO | Eisai Inc |
| April 29, 2016 | NDA208277 | Perampanel FYCOMPA | Catalyst Pharms |
| February 13, 2015 | NDA206947 | Lenvatinib LENVIMA | Eisai Inc |
| October 22, 2012 | NDA202834 | Perampanel FYCOMPA | Catalyst Pharms |
| March 3, 2011 | NDA201367 | Rufinamide BANZEL | Eisai Inc |
| November 15, 2010 | NDA201532 | Eribulin mesylate HALAVEN | Eisai Inc |
| July 23, 2010 | NDA022568 | Donepezil hydrochloride ARICEPT | Eisai Inc |
| November 14, 2008 | NDA021911 | Rufinamide BANZEL | Eisai Inc |
| November 25, 1996 | NDA020690 | Donepezil hydrochloride ARICEPT | Eisai Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2021
-
March 15, 2021 · Class II · Terminated · D-0472-2021 · Rufinamide
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- 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