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montelukast sodium

Pharmaranks rates Montelukast Sodium 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Montelukast Sodium is a leukotriene receptor antagonist used to treat Asthma, Perennial Allergic Rhinitis.

Leukotriene Receptor Antagonist · by Rising

Generic of Singulair

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 21, 2026·How we rate
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Key facts

Active ingredient
Montelukast Sodium
Form
Powder, Tablet, Tablet, chewable
Strength
Montelukast Sodium EQ 4MG Base · Montelukast Sodium EQ 5MG Base
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Rising
Half-life
about 2.7 to 5.5 hours (how long it stays in your system)
FDA application
ANDA209011

How long does Montelukast Sodium stay in your body?

The elimination half-life of montelukast sodium is about 2.7 to 5.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the mean range in healthy young adults; the half-life is somewhat longer in older adults and in people with mild-to-moderate liver impairment (about 7.4 hours). No active metabolite with a materially longer half-life is present.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: MONTELUKAST SODIUM tablet (DailyMed) — Clinical Pharmacology, Pharmacokinetics.

Drug class

May treat (source: NIH RxClass)

See how Montelukast Sodium ranks — best-rated leukotriene receptor antagonist for:

Dosage forms

Powder, Tablet and Tablet, chewable

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

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Frequently asked questions

What does Montelukast Sodium treat?
Montelukast Sodium (Montelukast Sodium) may be used to treat asthma, perennial allergic rhinitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How is Montelukast Sodium rated?
pharmaranks gives Montelukast Sodium a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
Is there a coupon or discount for Montelukast Sodium?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Montelukast Sodium. To pay less, Montelukast Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Montelukast Sodium?
Montelukast Sodium is marketed by Rising. You can see Rising's full profile, rating, and other products on pharmaranks.
Is Montelukast Sodium a brand-name or generic drug?
Montelukast Sodium is a generic medication; its active ingredient is Montelukast Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Montelukast Sodium available over the counter?
No. Montelukast Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Montelukast Sodium come in?
Montelukast Sodium is currently marketed as powder, tablet and tablet, chewable, per the FDA's National Drug Code Directory.
What class of drug is Montelukast Sodium?
Montelukast Sodium is classified as leukotriene receptor antagonist, per the FDA's Established Pharmacologic Class.
Is Montelukast Sodium FDA-registered?
Montelukast Sodium is on record with the U.S. FDA under application number ANDA209011. You can verify this on its official FDA label.
Has Montelukast Sodium been recalled by the FDA?
Montelukast Sodium has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Montelukast Sodium safe?
There's no single safe-or-not verdict. pharmaranks gives Montelukast Sodium a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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