PillMontelukast Sodium
Brands: Montelukast · Singulair · Montelukast Sodium
16 active makers
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US acquisition costNADAC · per unit
Average across 13 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it16 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Bryant Ranch Prepack | repackager | 16 | SUPPLYING |
| Proficient Rx LP | unknown | 10 | SUPPLYING |
| Camber Pharmaceuticals, Inc. | unknown | 5 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 5 | SUPPLYING |
| Unichem Pharmaceuticals (USA), Inc. | unknown | 4 | SUPPLYING |
| Preferred Pharmaceuticals Inc. | unknown | 3 | SUPPLYING |
| Accord Healthcare Inc. | unknown | 3 | SUPPLYING |
| NuCare Pharmaceuticals, Inc. | unknown | 3 | SUPPLYING |
| Direct_Rx | unknown | 2 | SUPPLYING |
| Organon LLC | unknown | 2 | SUPPLYING |
| Major Pharmaceuticals | unknown | 2 | SUPPLYING |
| Rising Pharma Holdings, Inc. | unknown | 2 | SUPPLYING |
| PD-Rx Pharmaceuticals, Inc. | unknown | 2 | SUPPLYING |
| Cardinal Health 107, LLC | unknown | 1 | SUPPLYING |
| A-S Medication Solutions | unknown | 1 | SUPPLYING |
+ 1 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Feb 7, 2023RECALLRecall (Class II): Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; …
CGMP Deviations: recalling drug products following an FDA inspection. — Recalling firm: Accord Healthcare, Inc. — United States including Puerto Rico and Canada
- Aug 20, 2018RECALLRecall (Class II): Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jad…
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. — Recalling firm: Hetero Labs Limited Unit V — Nationwide in the USA
- Aug 15, 2018RECALLRecall (Class I): Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherl…
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. — Recalling firm: Hetero Labs Limited Unit V — U.S.A. Nationwide
- Jan 7, 2017RECALLRecall (Class III): Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway…
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle. — Recalling firm: Hetero USA Inc — US Nationwide