Updated Nov 4, 2026FDA and CMS public dataIndependent · free · not health advice
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Drugs/Montelukast 10 mg tablet
Asthma / allergy

Montelukast 10 mg tablet

Public data on montelukast from CMS and FDA: what pharmacies have paid for it, how many generic applications FDA has approved, and whether it appears in FDA's shortage or recall records.

$0.0432
NADAC per ea (2026-11)
approximate acquisition cost, not a retail price
-41%
change over five years
peak $0.2670 in 2013-11
49
approved generic applications (ANDAs) on record for Montelukast Sodium
32 with a product still marketed · first 2012
Not listed
in FDA's current shortage list
Montelukast Sodium Tablet, Chewable: To Be Discontinued

NADAC per unit, monthly

MONTELUKAST SOD 10 MG TABLET
Show as table
MonthNADAC per unit ($)
2013-110.26695
2014-020.23730
2014-050.21907
2014-080.20815
2014-110.19969
2015-020.19182
2015-050.17832
2015-080.16580
2015-110.16393
2016-020.15919
2016-050.15460
2016-080.14387
2016-110.12997
2017-020.12194
2017-050.09909
2017-080.09474
2017-110.08960
2018-020.08776
2018-050.07338
2018-080.07881
2018-110.07222
2019-020.05768
2019-050.05527
2019-080.06156
2019-110.06520
2020-020.06396
2020-050.06450
2020-080.06714
2020-110.06946
2021-020.08596
2021-050.07514
2021-080.08286
2021-110.07272
2022-020.05994
2022-050.06563
2022-080.06471
2022-110.06630
2023-020.05837
2023-050.06243
2023-080.06569
2023-110.06442
2024-020.06487
2024-050.05275
2024-080.05156
2024-110.05164
2025-020.05039
2025-050.05278
2025-080.05210
2025-110.04991
2026-020.04505
2026-050.04299
2026-080.04090
2026-110.04321

Source: CMS NADAC weekly files, generic rows, monthly median of weekly averages · data as of 2026-11. Figures can change and may contain errors in the source data. Check the original source before relying on them.

Recall records mentioning montelukast

openFDA enforcement records, by year reported.

20236
20201
20182
20172
20151
20141
20131

14 records since 2012. A record is one product or lot, not one recall event. Combination products that contain montelukast are included.

What these numbers mean

NADAC is what retail pharmacies pay on average to buy the drug, published by CMS. It does not include rebates and is not what you pay at the counter. ANDA counts include all strengths and forms and applications whose products are now discontinued.

Most recent recall records

Class IITerminated
Montelukast sodium tablets
Reason category: Sterility / contamination
FDA recall number D-0086-2024
Class IITerminated
Montelukast sodium usp
Reason category: cGMP deviations
FDA recall number D-0557-2023
Class IIITerminated
Montelukast sodium oral granules usp
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0510-2023
Class IIOngoing
Montelukast sodium tablets
Reason category: cGMP deviations
FDA recall number D-0518-2023
Class IITerminated
Montelukast sodium tablets
Reason category: cGMP deviations
FDA recall number D-0476-2023

Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.

Articles that mention montelukast

7 GxRadar articles cite or discuss this drug.

MONTELUKAST · NADAC
Price histories · Data story · 5 min

What pharmacies paid for montelukast, 2013 to 2026

Federal NADAC data show the pharmacy cost of a generic 10 mg montelukast tablet fell 84 percent from 2013 to 2026. The year-by-year record, the 2012 generic launch and the 2020 boxed warning.

Labels & identifiers · Explainer · 6 min

Boxed warnings, FDA's most prominent label warning, explained

What 21 CFR 201.57 requires of a boxed warning, how many prescription labels carry one (about a third, by two counts 14 years apart), and why a generic's box matches the brand's.

1234STEP BY STEP
Cash price & comparison · How-to guide · 6 min

How to compare pharmacy cash prices for a generic prescription

A 2014 phone survey found one generic antibiotic priced from $5 to $229 in a single county. How to compare cash quotes by phone, and how to read them against NADAC.

The approval pathway · Explainer · 5 min

Pediatric exclusivity and the six months it adds before generics

A brand company that studies its drug in children at FDA's written request can win six more months of protection from generics. How the 1997 incentive works, what it attaches to, and what FDA's own lists show.

Labels & identifiers · Explainer · 5 min

Medication Guides and patient package inserts

What 21 CFR Part 208 requires, when a pharmacy must hand over a Medication Guide, how patient package inserts differ, and where FDA's one-page replacement proposal stands.

PRICE INDEX · 2014 = 100
Benchmarks & how prices are set · Data story · 6 min

The brand-generic gap in NADAC

In CMS's Oct. 28, 2026 cost file, brand tablets and capsules cost pharmacies a median 21 times the matching generic. For amlodipine the multiple was 857. Where the gap is widest, and where it nearly closes.