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Banzel

rufinamide · Tablet, Film Coated

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Banzel
Generic name
rufinamide
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Eisai Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
55% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Rufinamide 200 mg/1 1092357 View
Rufinamide 400 mg/1 1092357 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021911
Application type
NDA · New Drug Application
Approval date
November 14, 2008
Sponsor
EISAI INC
Products on application
3
Submissions recorded
10
Products approved under application 021911.
Product Trade name Form Strength Ingredient Status TE Flags
021911-001 BANZEL TABLET RUFINAMIDE Discontinued — RLD
021911-002 BANZEL TABLET RUFINAMIDE Prescription AB RLD
021911-003 BANZEL TABLET RUFINAMIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021911.
Type No. Action Status Date Review
Supplement 17 Labeling Approved November 28, 2019 Standard
Supplement 14 Manufacturing (CMC) Approved June 17, 2016 Standard
Supplement 13 Labeling Approved June 25, 2015 Standard
Supplement 12 Labeling Approved February 12, 2015 Standard
Supplement 10 Manufacturing (CMC) Approved June 6, 2013 Standard
Supplement 8 REMS Approved June 10, 2011 N/A
Supplement 7 REMS Approved March 3, 2011 N/A
Supplement 5 Labeling Approved November 8, 2010 Standard
Supplement 4 Labeling Approved October 16, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved November 14, 2008 Standard

Review documents

  • 0 · Supplement · December 2, 2019
  • 0 · Supplement · November 29, 2019
  • 0 · Supplement · November 29, 2019
  • 0 · Supplement · July 1, 2015
  • 0 · Supplement · June 26, 2015
  • 0 · Supplement · March 3, 2015
  • 0 · Supplement · February 17, 2015
  • 0 · Supplement · June 3, 2011
  • 0 · Supplement · March 8, 2011
  • 0 · Supplement · March 7, 2011
  • 0 · Supplement · November 10, 2010
  • 0 · Supplement · November 8, 2010
  • 0 · Supplement · November 24, 2009
  • 0 · Original application · February 19, 2009
  • 0 · Original application · February 19, 2009
  • 0 · Original application · November 18, 2008
  • 0 · Original application · November 17, 2008

Adverse event reports

Source: openFDA FAERS
2,575
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: RUFINAMIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
62856-582-04 62856-582 Eisai Inc. 4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04) August 8, 2018
62856-582-52 62856-582 Eisai Inc. 120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52) November 14, 2008
62856-583-14 62856-583 Eisai Inc. 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14) August 8, 2018
62856-583-52 62856-583 Eisai Inc. 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52) November 14, 2008
62856-582 62856-582 Eisai Inc. — November 14, 2008
62856-583 62856-583 Eisai Inc. — November 14, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 10 sections on this page.