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SINGULAIR

montelukast sodium · Tablet, Chewable

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
SINGULAIR
Generic name
montelukast sodium
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
NDA · NDA
Labeler
Organon LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
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
Montelukast Sodium 4 mg/1 200224 View
Montelukast Sodium 5 mg/1 200224 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
4

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
Leukotriene Receptor Antagonist [EPC] EPC All 10 members
Leukotriene Receptor Antagonists [MoA] MoA All 10 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020830
Application type
NDA · New Drug Application
Approval date
February 20, 1998
Sponsor
ORGANON
Products on application
2
Submissions recorded
55
Products approved under application 020830.
Product Trade name Form Strength Ingredient Status TE Flags
020830-001 SINGULAIR TABLET, CHEWABLE MONTELUKAST SODIUM Prescription AB RLD RS
020830-002 SINGULAIR TABLET, CHEWABLE MONTELUKAST SODIUM Discontinued AB RLD

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 020830.
Type No. Action Status Date Review
Supplement 76 Labeling Approved February 22, 2021 Standard
Supplement 75 Labeling Approved April 29, 2020 Standard
Supplement 74 Labeling Approved August 9, 2019 Standard
Supplement 73 Labeling Approved December 21, 2018 Standard
Supplement 72 Labeling Approved December 21, 2018 Standard
Supplement 71 Labeling Approved December 13, 2016 Standard
Supplement 70 Labeling Approved November 26, 2014 Standard
Supplement 67 Manufacturing (CMC) Approved October 29, 2014 Standard
Supplement 68 Labeling Approved December 30, 2013 Standard
Supplement 66 Labeling Approved March 21, 2013 Standard
Supplement 63 Labeling Approved October 18, 2012 Unknown
Supplement 64 Labeling Approved September 27, 2012 Unknown
Supplement 61 Efficacy Approved March 26, 2012 Standard
Supplement 62 Labeling Approved December 16, 2011 Unknown
Supplement 55 Labeling Approved June 10, 2011 Unknown
Supplement 59 Labeling Approved April 27, 2011 Unknown
Supplement 56 Labeling Approved August 10, 2010 Unknown
Supplement 53 Labeling Approved April 26, 2010 Standard
Supplement 52 Labeling Approved August 19, 2009 Standard
Supplement 51 Labeling Approved January 27, 2009 Standard
Supplement 50 Labeling Approved April 24, 2008 Standard
Supplement 49 Labeling Approved April 21, 2008 Standard
Supplement 48 Labeling Approved March 7, 2008 Standard
Supplement 47 Labeling Approved December 7, 2007 Standard
Supplement 43 Labeling Approved April 13, 2007 Standard
Supplement 38 Efficacy Approved April 13, 2007 Unknown
Supplement 41 Labeling Approved December 8, 2006 Standard
Supplement 40 Labeling Approved May 19, 2006 Standard
Supplement 36 Efficacy Approved November 30, 2005 Standard
Supplement 35 Efficacy Approved July 27, 2005 Unknown
Supplement 39 Labeling Approved June 27, 2005 Standard
Supplement 37 Labeling Approved May 26, 2005 Standard
Supplement 34 Labeling Approved December 29, 2004 Standard
Supplement 33 Labeling Approved November 15, 2004 Standard
Supplement 29 Labeling Approved December 19, 2003 Standard
Supplement 28 Labeling Approved November 5, 2003 Standard
Supplement 26 Labeling Approved October 2, 2003 Standard
Supplement 20 Efficacy Approved December 31, 2002 Standard
Supplement 21 Manufacturing (CMC) Approved October 7, 2002 Standard
Supplement 19 Manufacturing (CMC) Approved February 11, 2002 Standard
Supplement 11 Efficacy Approved November 23, 2001 Standard
Supplement 16 Labeling Approved October 26, 2001 Standard
Supplement 14 Labeling Approved August 2, 2001 Standard
Supplement 15 Manufacturing (CMC) Approved May 9, 2001 Standard
Supplement 10 Labeling Approved October 17, 2000 Standard
Supplement 12 Manufacturing (CMC) Approved September 5, 2000 Standard
Supplement 8 Efficacy Approved March 3, 2000 Standard
Supplement 7 Manufacturing (CMC) Approved July 28, 1999 Standard
Supplement 1 Labeling Approved February 12, 1999 Standard
Supplement 5 Manufacturing (CMC) Approved January 21, 1999 Standard
Supplement 6 Labeling Approved December 1, 1998 Standard
Supplement 4 Labeling Approved September 18, 1998 Standard
Supplement 3 Labeling Approved April 30, 1998 Standard
Supplement 2 Labeling Approved April 2, 1998 Standard
Original application 1 Type 3 - New Dosage Form Approved February 20, 1998 Standard

Review documents

  • 0 · Supplement · February 24, 2021
  • 0 · Supplement · February 24, 2021
  • 0 · Supplement · February 23, 2021
  • 0 · Supplement · December 4, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · August 12, 2019
  • 0 · Supplement · August 12, 2019
  • 0 · Supplement · December 31, 2018
  • 0 · Supplement · December 31, 2018
  • 0 · Supplement · December 26, 2018
  • 0 · Supplement · December 26, 2018
  • 0 · Supplement · December 15, 2016
  • 0 · Supplement · December 14, 2016
  • 0 · Supplement · December 19, 2014
  • 0 · Supplement · November 28, 2014
  • 0 · Supplement · December 31, 2013
  • 0 · Supplement · December 31, 2013
  • 0 · Supplement · March 26, 2013
  • 0 · Supplement · March 22, 2013
  • 0 · Supplement · October 22, 2012
  • 0 · Supplement · October 22, 2012
  • 0 · Supplement · October 2, 2012
  • 0 · Supplement · September 28, 2012
  • 0 · Supplement · March 28, 2012
  • 0 · Supplement · March 27, 2012
  • 0 · Supplement · December 21, 2011
  • 0 · Supplement · December 20, 2011
  • 0 · Supplement · June 17, 2011
  • 0 · Supplement · May 3, 2011
  • 0 · Supplement · April 29, 2011

Adverse event reports

Source: openFDA FAERS
121,070
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: MONTELUKAST SODIUM. 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
78206-170-01 78206-170 Organon LLC 30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01) June 1, 2021
78206-173-01 78206-173 Organon LLC 30 TABLET, CHEWABLE in 1 BOTTLE (78206-173-01) June 1, 2021
78206-170 78206-170 Organon LLC — June 1, 2021
78206-173 78206-173 Organon LLC — June 1, 2021

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.