Montelukast Sodium Tablet, Chewable shortage
Montelukast Sodium Tablet, Chewable is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Oct 2, 2026.
Organon is permanently stopping production of its chewable montelukast sodium 4 mg tablets. Other makers not reporting a shortage still list chewable montelukast sodium 4 mg tablets as available.
Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Montelukast Sodium Tablet, Chewable. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Nov 17, 2025Currently in shortage1 of 1 product affected.
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Nov 17, 2025First reported to the FDA1 product first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Organon 📞 844-674-3200 1 NDC click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01) | — | — | Discontinuation of the manufacture of the drug | — |
These rows are manufacturer reports to the FDA for Montelukast Sodium Tablet, Chewable — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Montelukast Sodium Tablet, Chewable? options further down this page.
Why is Montelukast Sodium Tablet, Chewable in shortage?
Organon, the company that makes the brand-name chewable tablet Singulair, has reported to the FDA that they are permanently stopping the manufacture of their 4 mg chewable tablet (the specific package with NDC 78206-170-01). They did not share a detailed public reason for why they made this decision — just that they are discontinuing production of that particular product.
It's worth knowing that this report covers only Organon's version of this specific chewable tablet. It does not mean that every manufacturer is stopping — other companies that make montelukast chewable tablets are reported on separately and may not be affected by this same decision.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Montelukast Sodium Tablet, Chewable, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Montelukast Sodium Tablet, Chewable?
Montelukast sodium chewable tablets (the 4 mg strength) are currently on the FDA drug-shortage list. If you or your child take this medicine for asthma or allergies, please read on so you know what this means and what to do next.
The affected strength is the 4 mg chewable tablet. Right now, no source is reported as available for this strength through the manufacturer on this record. The reason listed is that Organon is discontinuing its Singulair 4 mg chewable tablet, so this particular supply problem may be permanent rather than short-term. Because of that, a conversation with your prescriber or pharmacist is the right next step.
Please keep taking your medicine as prescribed. Here is how to move forward:
- Do not stop, skip, or change the dose on your own.
- Ask your pharmacy to check other manufacturers and wholesalers. The same medicine, montelukast sodium 4 mg chewable, is also made by other companies such as Torrent Pharmaceuticals, Ajanta Pharma, and Unichem — your pharmacy may be able to source one of these, though it may not be in local stock.
- If your exact product cannot be found, ask your prescriber or pharmacist about other options.
Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle these calls.
This is general, national information and may not match your local pharmacy's actual stock.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.
Where else can I get Montelukast Sodium Tablet, Chewable?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Montelukast Sodium Tablet, Chewable is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Same medicine, other manufacturers (not reported short)
Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:
| Product | Strength | Form / route | Manufacturer | NDC |
|---|---|---|---|---|
| Montelukast | MONTELUKAST SODIUM 10 mg/1 | Tablet, Film Coated · Oral | Sandoz Inc | 00781-5560-13 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet, Film Coated · Oral | Major Pharmaceuticals | 00904-6808-06 |
| Montelukast Sodium | MONTELUKAST SODIUM 4 mg/1 | Tablet, Chewable · Oral | Torrent Pharmaceuticals Limited | 13668-0079-05 |
| Montelukast Sodium | MONTELUKAST SODIUM 5 mg/1 | Tablet, Chewable · Oral | Torrent Pharmaceuticals Limited | 13668-0080-05 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet · Oral | Torrent Pharmaceuticals Limited | 13668-0081-05 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet · Oral | Rising Pharma Holdings, Inc. | 16571-0100-09 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet, Film Coated · Oral | Accord Healthcare Inc. | 16729-0119-10 |
| Montelukast Sodium | MONTELUKAST SODIUM 4 mg/1 | Tablet, Chewable · Oral | Ajanta Pharma USA Inc. | 27241-0016-03 |
| Montelukast Sodium | MONTELUKAST SODIUM 5 mg/1 | Tablet, Chewable · Oral | Ajanta Pharma USA Inc. | 27241-0017-03 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet, Coated · Oral | Ajanta Pharma USA Inc. | 27241-0018-03 |
| Montelukast Sodium | MONTELUKAST SODIUM 10 mg/1 | Tablet, Film Coated · Oral | Unichem Pharmaceuticals (USA), Inc. | 29300-0220-01 |
| Montelukast Sodium | MONTELUKAST SODIUM 4 mg/1 | Tablet, Chewable · Oral | Unichem Pharmaceuticals (USA), Inc. | 29300-0221-10 |
Alternative dosage forms of Montelukast Sodium
A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:
Therapeutic equivalents & pricing 21 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| Montelukast Sodium 4 mg | Torrent | 500 tablets | $0.075 | AB | Availability likely |
| montelukast sodium 4 mg | Unichem | 1000 tablets | $0.075 | AB | Availability likely |
| Montelukast sodium 4 mg | Macleods | 30 tablets | $0.075 | AB | Availability likely |
| Montelukast Sodium 4 mg | AvPAK | 1 tablet | $0.075 | AB | Availability likely |
| Montelukast Sodium 4 mg | Rising | 30 tablets | $0.075 | AB | Availability likely |
| Montelukast Sodium 4 mg | Chartwell | 30 tablets | $0.075 | AB | Availability likely |
| Montelukast Sodium 4 mg | Lannett | 30 tablets | $0.086 | AB | FDA listed |
| Montelukast Sodium 4 mg | Ajanta | 30 tablets | $0.086 | — | FDA listed |
| montelukast sodium 4 mg | Camber | 100 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | AvKARE | 1000 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | PD-Rx | 21 tablets | — | AB | FDA listed |
| montelukast sodium 4 mg | A-S | 30 tablets | — | AB | FDA listed |
| montelukast sodium 4 mg | A-S | 30 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | Dr.Reddy's | 500 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | Proficient | 30 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | Proficient | 30 tablets | — | — | FDA listed |
| Montelukast Sodium 4 mg | Amneal | 30 tablets | — | — | FDA listed |
| Montelukast Sodium 4 mg | Aurobindo | 500 tablets | — | AB | FDA listed |
| Montelukast Sodium 4 mg | Proficient | 30 tablets | — | AB | FDA listed |
| montelukast sodium 4 mg | Bryant | 30 tablets | — | AB | FDA listed |
| Singulair 4 mg | Organon | 30 tablets | — | — | FDA listed |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Other drugs in the same treatment class
These are different medicines — not other versions of Montelukast Sodium Tablet, Chewable — that fall in the same broad treatment class (leukotriene receptor antagonists) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.
Identity & classification
Where does this data come from?
Other pulmonary/allergy shortages
Montelukast Sodium Tablet, Chewable shortage FAQs
Is Montelukast Sodium Tablet, Chewable in shortage?
Which products are affected?
When will Montelukast Sodium Tablet, Chewable be available again?
Can I still get Montelukast Sodium somewhere?
What should I do if I take Montelukast Sodium Tablet, Chewable?
Still have a question about the Montelukast Sodium Tablet, Chewable shortage?
Ask a pharmacist about this shortage →View Montelukast Sodium Tablet, Chewable on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.