DEA schedule
Is montelukast a controlled substance?
Federal schedule for montelukast from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Montelukast is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and montelukast is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 93 prescription listings from 37 labelers, none with a DEA schedule |
| DEA controlled substances list | montelukast is not on the list |
Montelukast NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 78206-171 | SINGULAIR | granule | 4 mg/1 | Organon LLC | None |
| 78206-170 | SINGULAIR | tablet, chewable | 4 mg/1 | Organon LLC | None |
| 78206-173 | SINGULAIR | tablet, chewable | 5 mg/1 | Organon LLC | None |
| 78206-172 | SINGULAIR | tablet, film coated | 10 mg/1 | Organon LLC | None |
| 33342-102 | Montelukast | tablet | 10 mg/1 | Macleods Pharmaceuticals Limited | None |
| 67046-2060 | Montelukast | tablet | 10 mg/1 | Coupler LLC | None |
| 68001-361 | Montelukast | tablet | 10 mg/1 | BluePoint Laboratories | None |
| 68071-3855 | Montelukast | tablet | 10 mg/1 | NuCare Pharmaceuticals, Inc. | None |
| 68071-4034 | Montelukast | tablet | 10 mg/1 | NuCare Pharmaceuticals,Inc. | None |
| 63187-626 | MONTELUKAST | tablet, chewable | 5 mg/1 | Proficient Rx LP | None |
| 0781-5560 | Montelukast | tablet, film coated | 10 mg/1 | Sandoz Inc | None |
| 50090-6108 | Montelukast | tablet, film coated | 10 mg/1 | A-S Medication Solutions | None |
| 50090-6109 | MONTELUKAST | tablet, film coated | 10 mg/1 | A-S Medication Solutions | None |
| 50268-556 | Montelukast | tablet, film coated | 10 mg/1 | AvPAK | None |
| 68788-8099 | Montelukast | tablet, film coated | 10 mg/1 | Preferred Pharmaceuticals, Inc. | None |
| 70518-3133 | Montelukast | tablet, film coated | 10 mg/1 | REMEDYREPACK INC. | None |
| 71335-1979 | Montelukast | tablet, film coated | 10 mg/1 | Bryant Ranch Prepack | None |
| 71610-563 | Montelukast | tablet, film coated | 10 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | None |
| 72865-175 | Montelukast | tablet, film coated | 10 mg/1 | XLCare Pharmaceuticals Inc. | None |
| 82009-009 | Montelukast | tablet, film coated | 10 mg/1 | Quallent Pharmaceuticals Health LLC | None |
| 27241-015 | MONTELUKAST SODIUM | granule | 4 mg/1 | Ajanta Pharma USA Inc. | None |
| 59651-329 | Montelukast Sodium | granule | 4 mg/1 | Aurobindo Pharma Limited | None |
| 13668-531 | Montelukast Sodium | granule | 4 mg/500mg | Torrent Pharmaceuticals Limited | None |
| 13668-081 | Montelukast Sodium | tablet | 10 mg/1 | Torrent Pharmaceuticals Limited | None |
| 16571-100 | MONTELUKAST SODIUM | tablet | 10 mg/1 | Rising Pharma Holdings, Inc. | None |
| 63187-430 | Montelukast Sodium | tablet | 10 mg/1 | Proficient Rx LP | None |
| 65162-732 | Montelukast Sodium | tablet | 10 mg/1 | Amneal Pharmaceuticals LLC | None |
| 68788-8610 | Montelukast Sodium | tablet | 10 mg/1 | Preferred Pharmaceuticals Inc. | None |
| 69367-287 | Montelukast Sodium | tablet | 10 mg/1 | Westminster Pharmaceuticals, LLC | None |
| 70518-4753 | MONTELUKAST SODIUM | tablet | 10 mg/1 | REMEDYREPACK INC. | None |
| 13668-079 | Montelukast Sodium | tablet, chewable | 4 mg/1 | Torrent Pharmaceuticals Limited | None |
| 27241-016 | MONTELUKAST SODIUM | tablet, chewable | 4 mg/1 | Ajanta Pharma USA Inc. | None |
| 29300-221 | montelukast sodium | tablet, chewable | 4 mg/1 | Unichem Pharmaceuticals (USA), Inc. | None |
| 31722-727 | montelukast sodium | tablet, chewable | 4 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 33342-110 | Montelukast sodium | tablet, chewable | 4 mg/1 | Macleods Pharmaceuticals Limited | None |
| 42291-622 | Montelukast Sodium | tablet, chewable | 4 mg/1 | AvKARE | None |
| 43063-381 | Montelukast Sodium | tablet, chewable | 4 mg/1 | PD-Rx Pharmaceuticals, Inc. | None |
| 50090-2921 | montelukast sodium | tablet, chewable | 4 mg/1 | A-S Medication Solutions | None |
| 50090-7920 | montelukast sodium | tablet, chewable | 4 mg/1 | A-S Medication Solutions | None |
| 50268-573 | Montelukast Sodium | tablet, chewable | 4 mg/1 | AvPAK | None |
Showing 40 of 93 listings.
Questions
Is montelukast a controlled substance?
No. Montelukast is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and montelukast is not on the DEA controlled substances list.
Is montelukast a narcotic?
No. Montelukast is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Leukotriene Receptor Antagonist.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Montelukast
- What is Montelukast used for?FDA label uses
- Generic for SingulairFDA Orange Book
- What is Singulair used for?FDA label uses
- Is Singulair a controlled substance?Federal schedule
- Leukotriene Receptor Antagonists listFDA drug class
- NDC 78206-170Montelukast NDC record
- NDC 78206-171Montelukast NDC record
- NDC 78206-172Montelukast NDC record