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Montelukast Sodium 10 mg Tablet, Film Coated, 30-count

by Rising Pharma Holdings, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (57237-255-30)

NDC 57237-0255-30

🏷️ FDA NDC (as labeled) 57237-255-30 billing pads the product segment with a zero

This package

Contains30-count Pack sizes2 compare ↓

Also priced by: Part D plans $0.1490/unit — full pricing hub ↓

Also comes in: 90 tablets 57237-0255-90

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 57237-255-30

Product NDC 57237-255

11-digit billing NDC 57237025530

NCPDP billing unit EA — each (per item)

RxCUI 200224, 242438, 311759

UNII U1O3J18SFL

Application # ANDA202468

SPL Set ID 49669ac0-0bb5-4576-bed5-9e85e0d76a44

Established class (EPC) Leukotriene Receptor Antagonist

Mechanism of action Leukotriene Receptor Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2012-08-03

Route ORAL

Dosage form TABLET, FILM COATED

Substance MONTELUKAST SODIUM

GPI-14 44505050100330

GCN Seq No 038451

GCN 94444

HICL code 016911

Ingredient (HICL) Montelukast Sodium

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z4

Therapeutic class — intermediate (HIC2) Eicosanoids

HIC3 code Z4B

Therapeutic class — specific (HIC3) Leukotriene Receptor Antagonists

AHFS code 48:10.24.00

AHFS class Leukotriene Modifiers

FDB label name MONTELUKAST SOD 10 MG TABLET

FDB brand name Montelukast Sodium

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 57237-255-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57237-0255-30. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Leukotriene Receptor Antagonist class.

Pharmacologic class Leukotriene Receptor Antagonist

Drug family (ATC) Leukotriene receptor antagonists

How it works Leukotriene Receptor Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.

Application holderAUROBINDO PHARMA LTD

FDA applicationANDA202468 (ANDA)

Labeler code57237

First marketedAug 2012

Product typeHuman Prescription Drug

Portfolio525 products on file

🔎 All NDCs from Rising Pharma Holdings, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MONTELUKAST SOD 10 MG TABLET Ingredient Montelukast Sodium

📖 What it is MedlinePlus · NLM

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It does more than just treat allergies. Montelukast is used to help prevent and control asthma on a daily basis, to prevent breathing problems triggered by exercise, and to relieve...
What is montelukast actually used for — is it just for allergies?
This is a real and important concern — the FDA has placed its strongest warning on montelukast because of reported mental health side effects. These can include mood changes, agita...
I heard montelukast can affect your mood. Should I be worried?

📖 Read our full Montelukast guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Montelukast Sodium — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Montelukast Sodium (81 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / Brown

ShapeSquare

ImprintX;54

Size8 mm

ScoringNot scored

FlavorCherry

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1490	$4.47 / 30 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Montelukast Sodium 10 mg 00904-6808-06	Major	1 tablet	$0.042	AB	Availability likely	—
Montelukast Sodium 10 mg 13668-0081-05	Torrent	500 tablets	$0.042	AB	Availability likely	—
Montelukast Sodium 10 mg 16571-0100-09	Rising	90 tablets	$0.042	AB	Availability likely	—
Montelukast 10 mg 33342-0102-07	Macleods	30 tablets	$0.042	AB	Availability likely	—
Montelukast 10 mg 50268-0556-15	AvPAK	1 tablet	$0.042	AB	Availability likely	—
Montelukast 10 mg 68001-0361-03	BluePoint	500 tablets	$0.042	AB	Availability likely	—
Montelukast Sodium 10 mg 68084-0875-01	American	1 tablet	$0.042	AB	Availability likely	—
Montelukast Sodium 10 mg 69367-0287-05	Westminster	500 tablets	$0.042	AB	Availability likely	—
Montelukast 10 mg 82009-0009-10	Quallent	1000 tablets	$0.042	AB	Availability likely	—
Montelukast Sodium 10 mg 16729-0119-10	Accord	30 tablets	$0.042	AB	Availability likely	—
Singulair 10 mg 78206-0172-01	Organon	30 tablets	$9.212	AB	Availability likely	—
Montelukast 10 mg 00781-5560-13	Sandoz	10 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 27241-0018-03	Ajanta	30 tablets	—	—	FDA listed	—
montelukast sodium 10 mg 29300-0220-01	Unichem	100 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 31722-0726-01	Camber	100 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 43063-0762-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 50090-6108-00	A-S	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 50090-6109-00	A-S	90 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 55111-0725-01	Dr.	100 tablets	—	—	FDA listed	—
Montelukast Sodium 10 mg 55154-8075-00	Cardinal	1 tablet	—	AB	FDA listed	—
Montelukast Sodium 10 mgthis 57237-0255-30	Rising	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 63187-0430-30	Proficient	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 63187-0692-30	Proficient	30 tablets	—	—	FDA listed	—
Montelukast Sodium 10 mg 63187-0781-14	Proficient	14 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 65162-0732-03	Amneal	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 65862-0574-10	Aurobindo	10 tablets	—	AB	Discontinued	—
Montelukast Sodium 10 mg 67296-1926-03	Redpharm	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 67296-2248-03	Redpharm	30 tablets	—	AB	Discontinued	—
Montelukast Sodium 10 mg 68071-3355-09	NuCare	90 tablets	—	AB	FDA listed	—
Montelukast 10 mg 68071-3855-03	NuCare	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 68071-4034-09	NuCare	90 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 68071-4047-03	NuCare	30 tablets	—	AB	FDA listed	—
montelukast sodium 10 mg 68071-5278-03	NuCare	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 68788-8099-03	Preferred	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 68788-8610-03	Preferred	30 tablets	—	AB	FDA listed	—
montelukast sodium 10 mg 68788-8617-03	Preferred	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 70518-3133-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
montelukast sodium 10 mg 71205-0181-30	Proficient	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 71205-0778-30	Proficient	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 71335-0514-01	Bryant	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 71335-1979-01	Bryant	30 tablets	—	AB	FDA listed	—
montelukast sodium 10 mg 71335-1995-01	Bryant	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 71610-0563-30	Aphena	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 72189-0418-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 72789-0306-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Montelukast 10 mg 72865-0175-10	XLCare	1000 tablets	—	AB	FDA listed	—
Montelukast Sodium 10 mg 70518-4753-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2012

On the market since

Aug 2012

📍

2026

Currently FDA-listed

14 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Montelukast Sodium — the program that covers self-administered drugs. 16 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Montelukast Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$36.74M

Claims incl. refills

3.1M

Beneficiaries

2.3M

Spend / beneficiary

$15.93

Spend / claim

$11.90

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Montelukast Sodium — the ingredient across all brands.

Top reported reactions

Asthma14,956

Dyspnoea14,837

Cough9,067

Fatigue8,688

Headache8,236

Wheezing7,647

Pneumonia7,014

Age at onset

Neonate15

Infant35

Child699

Adolescent628

Adult13,193

Elderly7,237

Reporter sex

Male · 28%

Female · 71%

Unknown · 0%

Serious outcomes

Hospitalization32,694

Death4,919

Disabling3,799

Life-threatening3,493

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
57237-0255-30 You're viewing this	30 TABLET, FILM COATED in 1 BOTTLE (57237-255-30)	2012-08-03	Active
57237-0255-90	90 TABLET, FILM COATED in 1 BOTTLE (57237-255-90)	2012-08-03	Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 57237-0255-30?

NDC 57237-0255-30 is a 30-count package — 30 tablet, film coated in 1 bottle.

What is the difference between NDC 57237-0255-30 and NDC 57237-0255-90?

Both are Montelukast Sodium 10 mg Tablet, Film Coated — the drug itself is identical. NDC 57237-0255-30 is the 30-count package, while NDC 57237-0255-90 is the 90 tablets package.

What NDC number is used to bill for this package of Montelukast Sodium 10 mg Tablet, Film Coated?

Bill NDC 57237-0255-30 — the 11-digit billing format is 57237025530. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 57237-255-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57237-0255-30, written without dashes as 57237025530. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 57237-0255-30, the first segment (57237) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0255) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Rising Pharma Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (57237-0255-90). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Rising Pharma Holdings, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1) ] .

Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3) ] . In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1) ] .

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS See full prescribing information for complete boxed warning. Serious neuropsychiatric events have been reported in patients taking montelukast sodium ( 5.1 ). Discuss benefits and risks of m ontelukast sodium with patients and caregivers ( 5.1 ).

Monitor for neuropsychiatric symptoms in patients taking m ontelukast sodium ( 5.1 ). Discontinue montelukast sodium immediately if neuropsychiatric symptoms occur ( 5.1 ). Because the benefits of montelukast sodium may not outweigh the potential risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 , 5.1 ).

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older.

Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ).

1.1Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.

1.2Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

1.3Allergic Rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1) ] , reserve use for patients who have an inadequate response or intolerance to alternative therapies.

1.4Limitations of Use Montelukast sodium is not indicated for the treatment of an acute asthma attack.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 2 years and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ).

Perennial allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ). Dosage (by age): 15 years and older: one 10 mg tablet (2) . 6 to 14 years: one 5 mg chewable tablet (2) .

2 to 5 years: one 4 mg chewable tablet (2) . Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ).

2.1Asthma For asthma, administer montelukast sodium orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.2Exercise-Induced Bronchoconstriction (EIB) For prevention of EIB, administer a single dose of montelukast sodium orally at least 2 hours, before exercise. The following doses are recommended: Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB) Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age* one 5 mg chewable tablet * Safety and effectiveness in patients younger than 6 years of age have not been established. An additional dose of montelukast sodium should not be taken within 24 hours of a previous dose.

Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

2.3Allergic Rhinitis For allergic rhinitis, administer montelukast sodium orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: Table 3: Recommended Dosage in Seasonal Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age* one 4 mg chewable tablet * Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: Table 4: Recommended Dosage in Perennial Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.4Asthma and Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one montelukast sodium dose orally once daily in the evening. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS Montelukast Sodium Tablets USP, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Montelukast Sodium Chewable Tablets USP, 5 mg are pink colored, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side. The tablets may be mottled.

Montelukast Sodium Chewable Tablets USP, 4 mg are pink colored, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side. The tablets may be mottled. Tablets: 10 mg ( 3 ) Chewable tablets: 5 mg and 4 mg ( 3 )

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of montelukast sodium ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Do not prescribe montelukast sodium to treat an acute asthma attack ( 5.2 ). Advise patients to have appropriate rescue medication available ( 5.2 ). Inhaled corticosteroid may be reduced gradually.

Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids ( 5.3 ). Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium ( 5.4 ). Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported.

These events have been sometimes associated with the reduction of oral corticosteroid therapy ( 5.5 and 6.2 ). Inform patients with phenylketonuria that the 4 mg and 5 mg chewable tablets contain phenylalanine ( 5.6 ).

5.1Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor.

NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats [see Clinical Pharmacology (12.3) ] ; however, the mechanisms underlying montelukast sodium -associated NP events are currently not well understood.

Based upon the available data, it is difficult to identify risk factors for or quantify the risk of NP events with montelukast sodium use. Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium forpatients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3) ] .

In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium. Discuss the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or for new NP symptoms when taking montelukast sodium.

If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium. Therefore, continue to monitor and provide supportive care until symptoms resolve.

Re-evaluate the benefits and risks of restarting treatment with montelukast sodium if such events occur .

5.2Acute Asthma Montelukast sodium is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with montelukast sodium can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist.

5.3Concomitant Corticosteroid Use While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast sodium should not be abruptly substituted for inhaled or oral corticoste…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neuropsychiatric Events [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.

Adults and Adolescents 15 Years of Age and Older with Asthma Montelukast sodium has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse reactions reported with montelukast sodium occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo: Table 5: Adverse Reactions Occurring in ≥1% of Patients with an Incidence Greater than that in Patients Treated with Placebo * Number of patients tested (montelukast sodium and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159.

Montelukast 10 mg/day (%) (n=1955) Placebo (%) (n=1180) Body As A Whole Pain, abdominal 2.9

2.5Asthenia/fatigue 1.8

1.2Fever 1.5

0.9 Trauma 1

0.8Digestive System Disorders Dyspepsia 2.1

1.1Pain, dental 1.7 1 Gastroenteritis, infectious 1.5

0.5Nervous System/Psychiatric Headache 18.4

18.1Dizziness 1.9

1.4Respiratory System Disorders Influenza 4.2

3.9Cough 2.7

2.4Congestion, nasal 1.6

1.3Skin/Skin Appendages Disorder Rash 1.6

1.2Laboratory Adverse Reactions* ALT increased 2.1 2 AST increased 1.6

1.2 Pyuria 1

0.9The frequency of less common adverse reactions was comparable between montelukast sodium and placebo. The safety profile of montelukast sodium, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium. Cumulatively, 569 patients were treated with montelukast sodium for at least 6 months, 480 for one year, and 49 for two years in clinical trials.

With prolonged treatment, the adverse reaction profile did not significantly change. Pediatric Patients 6 to 14 Years of Age with Asthma Montelukast sodium has been evaluated for safety in 476 pediatric patients 6 to 14 years of age. Cumulatively, 289 pediatric patients were treated with montelukast sodium for at least 6 months, and 241 for one year or longer in clinical trials.

The safety profile of montelukast sodium in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile. In pediatric patients 6 to 14 years of age receiving montelukast sodium, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis. The frequency of less common adverse reactions was comparable between montelukast sodium and placebo.

With prolonged treatment, the adverse react…

🔄 Drug Interactions 45 words ▾

7 DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. Data Human Data Published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.

Animal Data In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).

8.2Lactation Risk Summary A published clinical lactation study reports the presence of montelukast in human milk. Data available on the effects of the drug on infants, either directly [see Use in Specific Populations (8.4) ] or through breast milk, do not suggest a significant risk of adverse reactions from exposure to montelukast sodium. The effects of the drug on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for montelukast sodium and any potential adverse reactions on the breastfed infant from montelukast sodium or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of montelukast sodium for asthma have been established in pediatric patients 6 to 14 years of age. Use of montelukast sodium for this indication is supported by evidence from well-controlled studies. Safety and efficacy data in this age group are similar to those seen in adults [see Adverse Reactions (6.1) , Clinical Pharmacology , Specific Populations (12.3) , and Clinical Studies (14.1 , 14.2) ].

The effectiveness of montelukast sodium for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 2 to 14 years of age have been established and is supported by extrapolation from the demonstrated effectiveness in patients 15 years of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. The safety of montelukast sodium chewable tablets 4 mg in pediatric patients 2 to 5 years of age with asthma has been demonstrated by adequate and well-controlled data [see Adverse Reactions (6.1) ] .

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use ~3 min read ▾

Effectiveness of montelukast sodium in this age group is extrapolated from the demonstrated effectiveness in patients 6 years of age and older with asthma and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. Effectiveness in this age group is supported by exploratory efficacy assessments from a large, well-controlled safety study conducted in patients 2 to 5 years of age. The safety of montelukast sodium chewable tablets 4 mg and 5 mg in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma.

A safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see Adverse Reactions (6.1) ] . The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. Growth Rate in Pediatric Patients A 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of montelukast sodium on growth rate in 360 patients with mild asthma, aged 6 to 8 years.

Treatment groups included montelukast 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device. For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. The primary comparison was the difference in growth rates between montelukast sodium and placebo groups.

Growth rates, expressed as least-squares (LS) mean (95% CI) in cm/year, for the montelukast sodium, placebo, and beclomethasone treatment groups were 5.67 (5.46, 5.88), 5.64 (5.42, 5.86), and 4.86 (4.64, 5.08), respectively. The differences in growth rates, expressed as least-squares (LS) mean (95% CI) in cm/year, for montelukast sodium minus placebo, beclomethasone minus placebo, and montelukast sodium minus beclomethasone treatment groups were 0.03 (-0.26, 0.31), -0.78 (-1.06, -0.49); and 0.81 (0.53, 1.09), respectively.

Growth rate (expressed as mean change in height over time) for each treatment group is shown in FIGURE 1. montelukast-fig1.jpg

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults.

The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.

🆘 Overdosage 59 words ▾

10 OVERDOSAGE No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT 1 ) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells).

CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis.

Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT 1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast inhibits physiologic actions of LTD 4 at the CysLT 1 receptor without any agonist activity.

12.2Pharmacodynamics Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD 4 -induced bronchoconstriction. In a placebo-controlled, crossover study (n=12), montelukast sodium inhibited early- and late-phase bronchoconstriction due to antigen challenge by 75% and 57%, respectively.

The effect of montelukast sodium on eosinophils in the peripheral blood was examined in clinical trials. In patients with asthma aged 2 years and older who received montelukast sodium, a decrease in mean peripheral blood eosinophil counts ranging from 9% to 15% was noted, compared with placebo, over the double-blind treatment periods. In patients with seasonal allergic rhinitis aged 15 years and older who received montelukast sodium, a mean increase of 0.2% in peripheral blood eosinophil counts was noted, compared with a mean increase of 12.5% in placebo-treated patients, over the double-blind treatment periods; this reflects a mean difference of 12.3% in favor of montelukast sodium.

The relationship between these observations and the clinical benefits of montelukast noted in the clinical trials is not known [see Clinical Studies (14) ] .

12.3Pharmacokinetics Absorption Montelukast is rapidly absorbed following oral administration. After administration of the 10 mg film-coated tablet to fasted adults, the mean peak montelukast plasma concentration (C max ) is achieved in 3 to 4 hours (T max ). The mean oral bioavailability is 64%.

The oral bioavailability and C max are not influenced by a standard meal in the morning. For the 5 mg chewable tablet, the mean C max is achieved in 2 to 2.5 hours after administration to adults in the fasted state. The mean oral bioavailability is 73% in the fasted state versus 63% when administered with a standard meal in the morning.

For the 4 mg chewable tablet, the mean C max is achieved 2 hours after administration in pediatric patients 2 to 5 years of age in the fasted state. The 4 mg oral granule formulation is bioequivalent to the 4 mg chewable tablet when administered to adults in the fasted state. The safety and effectiveness of montelukast in patients with asthma were demonstrated in clinical trials in which the 10 mg film-coated tablet and 5 mg chewable tablet formulations were administered in the evening without regard to the time of food ingestion.

The safety of montelukast in patients with asthma was also demonstrated in clinical trials in which the 4 mg chewable tablet formulation was administered in the evening without regard to the time of food ingestion. The safety and…

🧬 Mechanism of Action 182 words ▾

📦 How Supplied / Storage and Handling 166 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets USP: Montelukast Sodium Tablets USP, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Bottles of 30 NDC 57237-255-30 Bottles of 90 NDC 57237-255-90 Montelukast Sodium Chewable Tablets USP: Montelukast Sodium Chewable Tablets USP, 4 mg are pink colored, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side. The tablets may be mottled.

Bottles of 30 NDC 57237-212-30 Bottles of 90 NDC 57237-212-90 Montelukast Sodium Chewable Tablets USP, 5 mg are pink colored, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side. The tablets may be mottled. Bottles of 30 NDC 57237-213-30 Bottles of 90 NDC 57237-213-90 Storage Store montelukast 4 mg chewable tablets, 5 mg chewable tablets and montelukast 10 mg film-coated tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from moisture and light. Store in original package.

📋 Description 205 words ▾

11 DESCRIPTION Montelukast sodium, the active ingredient in montelukast sodium tablets and montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R -( E )]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The molecular formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18.

The structural formula is: Montelukast sodium USP is a hygroscopic, optically active, off-white to pale yellow colored powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10 mg film-coated montelukast sodium tablet USP contains 10.38 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and titanium dioxide.

Each 4 mg and 5 mg montelukast sodium chewable tablet USP contains 4.15 mg and 5.19 mg montelukast sodium USP, respectively, which are equivalent to 4 mg and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: artificial cherry flavor, aspartame, croscarmellose sodium, ferric oxide, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide ). Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with montelukast sodium use [see Warnings and Precautions (5.1) ] . Discuss the benefits and risks of montelukast sodium with patients when prescribing or continuing treatment with montelukast sodium [see Warnings and Precautions (5.1) ] .

Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking montelukast sodium [see Warnings and Precautions (5.1) ] . Instruct patients to discontinue montelukast sodium and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior [see Warnings and Precautions (5.1) ] . Advise patients to take montelukast sodium daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.

Advise patients that oral montelukast sodium is not for the treatment of acute asthma attacks. They should have appropriate short-acting inhaled β-agonist medication available to treat asthma exacerbations. Patients who have exacerbations of asthma after exercise should be instructed to have available for rescue a short-acting inhaled β-agonist.

Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB [see Warnings and Precautions (5.2) ] . Advise patients to seek medical attention if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed. Instruct patients to continue other anti-asthma medications as prescribed unless instructed by a physician.

Instruct patients with known aspirin sensitivity to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium [see Warnings and Precautions (5.4) ] . Inform phenylketonuric patients that the 4 mg and 5 mg chewable tablets contain phenylalanine (a source of aspartame) [see Warnings and Precautions (5.6) ] . Distributed by: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/22/2009 Revised: 05/2026

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Montelukast Sodium Tablets USP and Montelukast Sodium Chewable Tablets USP (mon te loo' kast soe' dee um) What is the most important information I should know about montelukast sodium? Serious mental health problems have happened in people taking montelukast sodium or even after treatment has stopped. This can happen in people with or without a history of mental health problems.

Stop taking montelukast sodium and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: agitation, including aggressive behavior or hostility attention problems bad or vivid dreams depression disorientation (confusion) feeling anxious irritability hallucinations (seeing or hearing things that are not really there) memory problems obsessive-compulsive symptoms restlessness sleep walking stuttering suicidal thoughts and actions (including suicide) tremor trouble sleeping uncontrolled muscle movements What is montelukast sodium?

Montelukast sodium is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium does not contain a steroid.

Montelukast sodium is used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 2 years and older. Do not take montelukast sodium if you need relief right away for a sudden asthma attack.

If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks. 2. Prevent exercise-induced asthma in people 6 years of age and older.

3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium is used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines: outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older, and indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 2 years and older.

Do not take montelukast sodium if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium tablets and montelukast sodium chewable tablets. Before taking montelukast sodium, tell your healthcare provider about all your medical conditions, including if you: are allergic to aspirin. have phenylketonuria.

Montelukast sodium chewable tablets contain aspartame, a source of phenylalanine. have or have had mental health problems. are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant, montelukast sodium may not be right for you. are breastfeeding or plan to breastfeed. It is not known if montelukast sodium passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium. Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium works, or montelukast sodium may affect how your other medicines work.

How should I take montelukast sodium? For anyone who takes montelukast sodium: Take montelukast sodium exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium to take, and when to take it .

Stop taking montelukast sodium and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking. You can take montelukast sodium with food or without food. If you or your child misses a dose of montelukast sodium, just take the next dose at your regular time.

Do not take 2 dose…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 57237-0240-01 · Rising 57237-0274-24 · Rising →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Montelukast Sodium 10 mg Tablet, Film Coated, 30-count

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0.9 Trauma 1

1.2 Pyuria 1

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

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