PillTimolol Maleate
Brands: Istalol · Timolol Maleate
11 active makers
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US acquisition costNADAC · per unit
Average across 28 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 it11 active · 1 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Somerset Therapeutics, LLC | unknown | 6 | SUPPLYING |
| Rising Pharma Holdings, Inc. | unknown | 6 | SUPPLYING |
| First Nation Group, LLC | unknown | 4 | SUPPLYING |
| Pacific Pharma, Inc. | unknown | 4 | SUPPLYING |
| Lifestar Pharma LLC | unknown | 4 | SUPPLYING |
| Bausch & Lomb Incorporated | unknown | 3 | SUPPLYING |
| Ingenus Pharmaceuticals, LLC | unknown | 2 | SUPPLYING |
| Bausch & Lomb Americas Inc. | unknown | 2 | SUPPLYING |
| NorthStar RxLLC | unknown | 1 | SUPPLYING |
| A-S Medication Solutions | unknown | 1 | SUPPLYING |
| Micro Labs Limited | unknown | 1 | SUPPLYING |
| Oceanside Pharmaceuticals | unknown | 1 | EXITED 2026 |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jul 5, 2025RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. — Recalling firm: FDC Limited — U.S Nationwide.
- Apr 18, 2025RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aur…
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Recalling firm: FDC Limited — U.S. Nationwide
- Jan 23, 2025RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Recalling firm: FDC Limited — Distributed to one (1) Us Distributor in NJ
- Dec 5, 2024RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Au…
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Recalling firm: FDC Limited — Distributed to one Us Distributor in NJ.
- Oct 29, 2024RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Recalling firm: FDC Limited — Distributed to one Us Distributor in NJ.
- Aug 12, 2024RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 6…
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Recalling firm: FDC Limited — Nationwide U.S.A.
- Jul 18, 2024RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…
Defective container; yellow colored spike from cap lodged in the nozzle — Recalling firm: FDC Limited — Nationwide in the US
- Apr 25, 2024RECALLRecall (Class II): Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (ND…
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. — Recalling firm: FDC Limited — New Jersey Only
- Nov 15, 2019RECALLRecall (Class III): Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Ph…
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml. — Recalling firm: Rising Pharmaceuticals, Inc. — U.S.A. Nationwide
- Nov 15, 2019RECALLRecall (Class III): Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed…
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml. — Recalling firm: Rising Pharmaceuticals, Inc. — U.S.A. Nationwide