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TEMODAR

Temozolomide · Capsule

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
TEMODAR
Generic name
Temozolomide
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Merck Sharp & Dohme LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
6
Packages
11
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Temozolomide 100 mg/1 313209 View
Temozolomide 140 mg/1 313209 View
Temozolomide 180 mg/1 313209 View
Temozolomide 20 mg/1 313209 View
Temozolomide 250 mg/1 313209 View
Temozolomide 5 mg/1 313209 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
17

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
Alkylating Activity [MoA] MoA All 23 members
Alkylating Drug [EPC] EPC All 23 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021029
Application type
NDA · New Drug Application
Approval date
August 11, 1999
Sponsor
MERCK SHARP DOHME
Products on application
6
Submissions recorded
31
Products approved under application 021029.
Product Trade name Form Strength Ingredient Status TE Flags
021029-001 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD
021029-002 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD
021029-003 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD
021029-004 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD
021029-005 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD
021029-006 TEMODAR CAPSULE TEMOZOLOMIDE Discontinued AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
No

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 021029.
Type No. Action Status Date Review
Supplement 38 Efficacy Approved September 14, 2023 Standard
Supplement 37 Efficacy Approved September 14, 2023 Standard
Supplement 36 Efficacy Approved September 14, 2023 Standard
Supplement 35 Labeling Approved November 20, 2020 Standard
Supplement 33 Labeling Approved November 22, 2019 Standard
Supplement 32 Labeling Approved October 6, 2017 Standard
Supplement 30 Labeling Approved February 24, 2017 Standard
Supplement 31 Labeling Approved February 12, 2016 Standard
Supplement 29 Labeling Approved September 18, 2015 Standard
Supplement 28 Labeling Approved April 2, 2015 Standard
Supplement 27 Manufacturing (CMC) Approved September 19, 2014 Priority
Supplement 26 Labeling Approved May 5, 2014 Standard
Supplement 24 Manufacturing (CMC) Approved March 20, 2014 Priority
Supplement 25 Manufacturing (CMC) Approved October 10, 2013 Priority
Supplement 22 Manufacturing (CMC) Approved January 8, 2013 Priority
Supplement 21 Labeling Approved June 3, 2011 Unknown
Supplement 20 Labeling Approved February 4, 2011 Unknown
Supplement 18 Labeling Approved April 26, 2010 Standard
Supplement 12 Manufacturing (CMC) Approved October 19, 2006 N/A
Supplement 11 Labeling Approved March 31, 2006 Standard
Supplement 10 Labeling Approved April 22, 2005 Standard
Supplement 9 Labeling Approved March 30, 2005 Standard
Supplement 8 Efficacy Approved March 15, 2005 Priority
Supplement 6 Labeling Approved July 15, 2004 Standard
Supplement 7 Labeling Approved June 29, 2004 Standard
Supplement 5 Efficacy Approved March 11, 2003 Priority
Supplement 3 Manufacturing (CMC) Approved March 5, 2002 Priority
Supplement 4 Labeling Approved January 18, 2002 Standard
Supplement 2 Manufacturing (CMC) Approved May 18, 2001 Priority
Supplement 1 Manufacturing (CMC) Approved June 9, 2000 Priority
Original application 1 Type 1 - New Molecular Entity Approved August 11, 1999 Priority

Review documents

  • 0 · Supplement · September 28, 2023
  • 0 · Supplement · September 28, 2023
  • 0 · Supplement · September 28, 2023
  • 0 · Supplement · September 15, 2023
  • 0 · Supplement · September 15, 2023
  • 0 · Supplement · September 15, 2023
  • 0 · Supplement · September 14, 2023
  • 0 · Supplement · September 14, 2023
  • 0 · Supplement · September 14, 2023
  • 0 · Supplement · November 25, 2020
  • 0 · Supplement · November 25, 2020
  • 0 · Supplement · November 26, 2019
  • 0 · Supplement · November 25, 2019
  • 0 · Supplement · October 12, 2017
  • 0 · Supplement · October 10, 2017
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 27, 2017
  • 0 · Supplement · February 18, 2016
  • 0 · Supplement · February 16, 2016
  • 0 · Supplement · September 23, 2015
  • 0 · Supplement · September 22, 2015
  • 0 · Supplement · April 7, 2015
  • 0 · Supplement · April 3, 2015
  • 0 · Supplement · May 6, 2014
  • 0 · Supplement · May 6, 2014
  • 0 · Supplement · January 9, 2013
  • 0 · Supplement · June 9, 2011
  • 0 · Supplement · June 7, 2011
  • 0 · Supplement · February 9, 2011
  • 0 · Supplement · April 29, 2010

Adverse event reports

Source: openFDA FAERS
20,950
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: TEMOZOLOMIDE. 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
0085-1366-03 0085-1366 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05) August 11, 1999
0085-1366-04 0085-1366 Merck Sharp & Dohme LLC 14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05) August 11, 1999
0085-1417-02 0085-1417 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-1417-02) / 1 CAPSULE in 1 PACKET (0085-1417-03) August 11, 1999
0085-1425-03 0085-1425 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-1425-03) / 1 CAPSULE in 1 PACKET (0085-1425-05) August 11, 1999
0085-1425-04 0085-1425 Merck Sharp & Dohme LLC 14 PACKET in 1 CARTON (0085-1425-04) / 1 CAPSULE in 1 PACKET (0085-1425-05) August 11, 1999
0085-1430-03 0085-1430 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05) August 11, 1999
0085-1430-04 0085-1430 Merck Sharp & Dohme LLC 14 PACKET in 1 CARTON (0085-1430-04) / 1 CAPSULE in 1 PACKET (0085-1430-05) August 11, 1999
0085-1519-03 0085-1519 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-1519-03) / 1 CAPSULE in 1 PACKET (0085-1519-05) August 11, 1999
0085-1519-04 0085-1519 Merck Sharp & Dohme LLC 14 PACKET in 1 CARTON (0085-1519-04) / 1 CAPSULE in 1 PACKET (0085-1519-05) August 11, 1999
0085-3004-03 0085-3004 Merck Sharp & Dohme LLC 5 PACKET in 1 CARTON (0085-3004-03) / 1 CAPSULE in 1 PACKET (0085-3004-05) August 11, 1999
0085-3004-04 0085-3004 Merck Sharp & Dohme LLC 14 PACKET in 1 CARTON (0085-3004-04) / 1 CAPSULE in 1 PACKET (0085-3004-05) August 11, 1999
0085-1366 0085-1366 Merck Sharp & Dohme LLC — August 11, 1999
0085-1417 0085-1417 Merck Sharp & Dohme LLC — August 11, 1999
0085-1425 0085-1425 Merck Sharp & Dohme LLC — August 11, 1999
0085-1430 0085-1430 Merck Sharp & Dohme LLC — August 11, 1999
0085-1519 0085-1519 Merck Sharp & Dohme LLC — August 11, 1999
0085-3004 0085-3004 Merck Sharp & Dohme LLC — August 11, 1999

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 · 10 sections on this page.