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Keppra

levetiracetam · 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
Keppra
Generic name
levetiracetam
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
UCB, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Levetiracetam 1000 mg/1 403884 View
Levetiracetam 250 mg/1 403884 View
Levetiracetam 500 mg/1 403884 View
Levetiracetam 750 mg/1 403884 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021035
Application type
NDA · New Drug Application
Approval date
November 30, 1999
Sponsor
UCB INC
Products on application
4
Submissions recorded
55
Products approved under application 021035.
Product Trade name Form Strength Ingredient Status TE Flags
021035-001 KEPPRA TABLET LEVETIRACETAM Prescription AB RLD
021035-002 KEPPRA TABLET LEVETIRACETAM Prescription AB RLD
021035-003 KEPPRA TABLET LEVETIRACETAM Prescription AB RLD
021035-004 KEPPRA TABLET LEVETIRACETAM 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.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8802142 June 7, 2031 001 No September 10, 2014
8802142 June 7, 2031 002 No September 10, 2014
8802142 June 7, 2031 003 No September 10, 2014
8802142 June 7, 2031 004 No September 10, 2014
8802142*PED December 7, 2031 001 No —
8802142*PED December 7, 2031 002 No —
8802142*PED December 7, 2031 003 No —
8802142*PED December 7, 2031 004 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 021035.
Type No. Action Status Date Review
Supplement 115 Labeling Approved March 12, 2024 Standard
Supplement 113 Labeling Approved August 31, 2023 Standard
Supplement 112 Labeling Approved August 17, 2023 Standard
Supplement 104 Labeling Approved September 30, 2020 Standard
Supplement 102 Efficacy Approved October 23, 2019 Standard
Supplement 100 Labeling Approved October 24, 2017 Standard
Supplement 99 Labeling Approved April 24, 2017 Standard
Supplement 96 Labeling Approved October 26, 2016 Standard
Supplement 95 Manufacturing (CMC) Approved February 4, 2016 Standard
Supplement 93 Labeling Approved March 10, 2015 Standard
Supplement 94 Labeling Approved August 7, 2014 Standard
Supplement 91 Labeling Approved March 7, 2014 Standard
Supplement 89 Labeling Approved July 25, 2013 Standard
Supplement 92 Manufacturing (CMC) Approved November 13, 2012 Standard
Supplement 85 Labeling Approved December 16, 2011 Standard
Supplement 83 Labeling Approved December 16, 2011 Standard
Supplement 74 Labeling Approved December 16, 2011 Standard
Supplement 73 Efficacy Approved December 16, 2011 Priority
Supplement 52 Labeling Approved December 16, 2011 Standard
Supplement 90 REMS Approved August 10, 2011 N/A
Supplement 80 Labeling Approved April 23, 2009 Standard
Supplement 79 Labeling Approved April 23, 2009 Standard
Supplement 78 Labeling Approved April 23, 2009 901 Required
Supplement 62 Labeling Approved September 12, 2007 Standard
Supplement 57 Efficacy Approved March 19, 2007 Standard
Supplement 55 Manufacturing (CMC) Approved August 16, 2006 N/A
Supplement 54 Labeling Approved August 15, 2006 Standard
Supplement 50 Efficacy Approved August 15, 2006 Unknown
Supplement 38 Labeling Approved January 24, 2006 Standard
Supplement 48 Manufacturing (CMC) Approved January 6, 2006 Standard
Supplement 40 Efficacy Approved June 21, 2005 Priority
Supplement 33 Labeling Approved October 26, 2004 Standard
Supplement 32 Labeling Approved October 26, 2004 Standard
Supplement 30 Labeling Approved September 3, 2003 Standard
Supplement 22 Manufacturing (CMC) Approved October 17, 2002 Standard
Supplement 19 Labeling Approved May 22, 2002 Standard
Supplement 13 Labeling Approved May 22, 2002 Standard
Supplement 18 Manufacturing (CMC) Approved May 7, 2002 Standard
Supplement 21 Manufacturing (CMC) Approved April 17, 2002 Standard
Supplement 20 Manufacturing (CMC) Approved April 1, 2002 Standard
Supplement 17 Manufacturing (CMC) Approved January 4, 2002 Standard
Supplement 16 Manufacturing (CMC) Approved January 4, 2002 Standard
Supplement 14 Manufacturing (CMC) Approved November 27, 2001 Standard
Supplement 12 Manufacturing (CMC) Approved November 27, 2001 Standard
Supplement 15 Manufacturing (CMC) Approved October 24, 2001 Standard
Supplement 10 Manufacturing (CMC) Approved July 5, 2001 Standard
Supplement 11 Manufacturing (CMC) Approved April 26, 2001 Standard
Supplement 9 Manufacturing (CMC) Approved December 4, 2000 Standard
Supplement 8 Manufacturing (CMC) Approved December 4, 2000 Standard
Supplement 7 Manufacturing (CMC) Approved October 4, 2000 Standard
Supplement 6 Manufacturing (CMC) Approved August 9, 2000 Standard
Supplement 5 Manufacturing (CMC) Approved July 27, 2000 Standard
Supplement 4 Manufacturing (CMC) Approved May 15, 2000 Standard
Supplement 3 Labeling Approved April 10, 2000 Standard
Original application 1 Type 1 - New Molecular Entity Approved November 30, 1999 Standard

Review documents

  • 0 · Supplement · March 13, 2024
  • 0 · Supplement · March 13, 2024
  • 0 · Supplement · March 13, 2024
  • 0 · Supplement · September 5, 2023
  • 0 · Supplement · September 1, 2023
  • 0 · Supplement · August 18, 2023
  • 0 · Supplement · August 18, 2023
  • 0 · Supplement · October 19, 2022
  • 0 · Supplement · October 2, 2020
  • 0 · Supplement · October 1, 2020
  • 0 · Supplement · October 24, 2019
  • 0 · Supplement · October 24, 2019
  • 0 · Supplement · October 30, 2017
  • 0 · Supplement · October 27, 2017
  • 0 · Supplement · April 27, 2017
  • 0 · Supplement · April 25, 2017
  • 0 · Supplement · November 1, 2016
  • 0 · Supplement · October 28, 2016
  • 0 · Supplement · March 12, 2015
  • 0 · Supplement · March 12, 2015
  • 0 · Supplement · August 11, 2014
  • 0 · Supplement · August 8, 2014
  • 0 · Supplement · March 11, 2014
  • 0 · Supplement · March 10, 2014
  • 0 · Supplement · July 30, 2013
  • 0 · Supplement · July 26, 2013
  • 0 · Supplement · December 21, 2011
  • 0 · Supplement · December 21, 2011
  • 0 · Supplement · December 21, 2011
  • 0 · Supplement · December 21, 2011

Adverse event reports

Source: openFDA FAERS
132,819
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: LEVETIRACETAM. 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.

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
50474-594-40 50474-594 UCB, Inc. 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-594-40) April 24, 2000
50474-595-40 50474-595 UCB, Inc. 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40) April 24, 2000
50474-596-40 50474-596 UCB, Inc. 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-596-40) April 24, 2000
50474-597-66 50474-597 UCB, Inc. 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-597-66) April 24, 2000
50474-594 50474-594 UCB, Inc. — April 24, 2000
50474-595 50474-595 UCB, Inc. — April 24, 2000
50474-596 50474-596 UCB, Inc. — April 24, 2000
50474-597 50474-597 UCB, Inc. — April 24, 2000

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

Generated September 25, 2026 · 12 sections on this page.