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Topamax

topiramate · Tablet, 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
Topamax
Generic name
topiramate
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Janssen Pharmaceuticals, 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
Topiramate 100 mg/1 1302827 View
Topiramate 200 mg/1 1302827 View
Topiramate 25 mg/1 1302827 View
Topiramate 50 mg/1 1302827 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, 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
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Cytochrome P450 3A4 Inducers [MoA] MoA All 54 members
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020505
Application type
NDA · New Drug Application
Approval date
December 24, 1996
Sponsor
JANSSEN PHARMS
Products on application
6
Submissions recorded
53
Products approved under application 020505.
Product Trade name Form Strength Ingredient Status TE Flags
020505-001 TOPAMAX TABLET TOPIRAMATE Prescription AB RLD RS
020505-002 TOPAMAX TABLET TOPIRAMATE Prescription AB RLD
020505-003 TOPAMAX TABLET TOPIRAMATE Discontinued —
020505-004 TOPAMAX TABLET TOPIRAMATE Prescription AB RLD
020505-005 TOPAMAX TABLET TOPIRAMATE Prescription AB RLD
020505-006 TOPAMAX TABLET TOPIRAMATE Discontinued —

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 020505.
Type No. Action Status Date Review
Supplement 68 Labeling Approved March 6, 2026 Standard
Supplement 67 Labeling Approved March 12, 2025 Standard
Supplement 65 Labeling Approved May 3, 2023 Standard
Supplement 64 Labeling Approved October 20, 2022 Standard
Supplement 62 Efficacy Approved January 13, 2022 Standard
Supplement 63 Labeling Approved June 30, 2021 Standard
Supplement 61 Labeling Approved June 8, 2020 Standard
Supplement 60 Labeling Approved May 2, 2019 Standard
Supplement 59 Labeling Approved December 27, 2018 Standard
Supplement 58 Labeling Approved June 19, 2018 Standard
Supplement 57 Labeling Approved May 12, 2017 Standard
Supplement 56 Manufacturing (CMC) Approved May 11, 2015 Standard
Supplement 55 Labeling Approved December 18, 2014 Standard
Supplement 54 Labeling Approved October 21, 2014 Standard
Supplement 52 Efficacy Approved March 28, 2014 Standard
Supplement 53 Labeling Approved January 29, 2014 Standard
Supplement 51 Manufacturing (CMC) Approved July 25, 2013 Standard
Supplement 50 Labeling Approved October 29, 2012 Standard
Supplement 42 Efficacy Approved July 15, 2011 Standard
Supplement 46 REMS Approved June 27, 2011 N/A
Supplement 45 Labeling Approved March 4, 2011 Standard
Supplement 40 Labeling Approved March 4, 2011 Standard
Supplement 37 Efficacy Approved December 22, 2009 Priority
Supplement 32 Labeling Approved December 22, 2009 Standard
Supplement 31 Labeling Approved December 22, 2009 Standard
Supplement 14 Labeling Approved December 22, 2009 Standard
Supplement 39 Labeling Approved April 23, 2009 Standard
Supplement 38 Labeling Approved April 23, 2009 901 Required
Supplement 36 Labeling Approved April 22, 2009 Standard
Supplement 29 Labeling Approved October 19, 2006 Standard
Supplement 26 Labeling Approved June 29, 2005 Standard
Supplement 18 Efficacy Approved June 29, 2005 Standard
Supplement 25 Labeling Approved August 11, 2004 Standard
Supplement 22 Efficacy Approved August 11, 2004 Standard
Supplement 19 Labeling Approved December 16, 2003 Standard
Supplement 17 Efficacy Approved December 16, 2003 Standard
Supplement 10 Labeling Approved December 16, 2003 Standard
Supplement 20 Labeling Approved June 12, 2003 Standard
Supplement 15 Labeling Approved June 3, 2003 Standard
Supplement 23 Labeling Approved April 15, 2003 Standard
Supplement 21 Labeling Approved April 15, 2003 Standard
Supplement 16 Labeling Approved November 26, 2002 Standard
Supplement 2 Efficacy Approved August 28, 2001 Standard
Supplement 13 Manufacturing (CMC) Approved October 24, 2000 Standard
Supplement 12 Manufacturing (CMC) Approved July 18, 2000 Standard
Supplement 11 Manufacturing (CMC) Approved May 15, 2000 Standard
Supplement 5 Labeling Approved May 1, 2000 Standard
Supplement 7 Manufacturing (CMC) Approved March 2, 2000 Standard
Supplement 9 Manufacturing (CMC) Approved January 4, 2000 Standard
Supplement 8 Manufacturing (CMC) Approved December 7, 1999 Standard
Supplement 3 Efficacy Approved October 1, 1999 Standard
Supplement 1 Efficacy Approved July 23, 1999 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 24, 1996 Standard

Review documents

  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 9, 2026
  • 0 · Supplement · March 17, 2025
  • 0 · Supplement · March 14, 2025
  • 0 · Supplement · May 4, 2023
  • 0 · Supplement · May 4, 2023
  • 0 · Supplement · October 24, 2022
  • 0 · Supplement · October 21, 2022
  • 0 · Supplement · January 19, 2022
  • 0 · Supplement · January 19, 2022
  • 0 · Supplement · July 1, 2021
  • 0 · Supplement · July 1, 2021
  • 0 · Supplement · June 9, 2020
  • 0 · Supplement · June 9, 2020
  • 0 · Supplement · May 3, 2019
  • 0 · Supplement · May 3, 2019
  • 0 · Supplement · December 30, 2018
  • 0 · Supplement · December 28, 2018
  • 0 · Supplement · June 26, 2018
  • 0 · Supplement · June 21, 2018
  • 0 · Supplement · May 17, 2017
  • 0 · Supplement · May 16, 2017
  • 0 · Supplement · December 19, 2014
  • 0 · Supplement · December 19, 2014
  • 0 · Supplement · October 23, 2014
  • 0 · Supplement · October 23, 2014
  • 0 · Supplement · April 2, 2014
  • 0 · Supplement · April 1, 2014
  • 0 · Supplement · January 31, 2014

Adverse event reports

Source: openFDA FAERS
96,821
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: TOPIRAMATE. 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
50458-639-65 50458-639 Janssen Pharmaceuticals, Inc. 60 TABLET, COATED in 1 BOTTLE (50458-639-65) January 1, 1997
50458-640-65 50458-640 Janssen Pharmaceuticals, Inc. 60 TABLET, COATED in 1 BOTTLE (50458-640-65) January 1, 1997
50458-641-65 50458-641 Janssen Pharmaceuticals, Inc. 60 TABLET, COATED in 1 BOTTLE (50458-641-65) January 1, 1997
50458-642-65 50458-642 Janssen Pharmaceuticals, Inc. 60 TABLET, COATED in 1 BOTTLE (50458-642-65) January 1, 1997
50458-639 50458-639 Janssen Pharmaceuticals, Inc. — January 1, 1997
50458-640 50458-640 Janssen Pharmaceuticals, Inc. — January 1, 1997
50458-641 50458-641 Janssen Pharmaceuticals, Inc. — January 1, 1997
50458-642 50458-642 Janssen Pharmaceuticals, Inc. — January 1, 1997

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 · 11 sections on this page.