Data / Drug companies / Timolol maleate
Timolol maleate: 20 companies and 56 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Timolol maleate is listed in the FDA National Drug Code Directory by 20 companies, with 56 products in commercial distribution. 41 of the products (73.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are solution/ drops; solution; solution, gel forming / drops, and the newest product started marketing on January 15, 2026.
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- Companies listing it
- 20
- Products
- 56
- Generic (ANDA) products
- 41 (73.2%)
- Application numbers
- 22
- Routes
- Ophthalmic, Oral
- Brand names
- Timoptic in Ocudose, Timoptic-XE, Timoptic, Timolol GFS, Istalol
- openFDA record search
- api.fda.gov
Companies that list timolol maleate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Somerset Therapeutics, LLC | 8 | solution/ drops; solution, gel forming / drops | Generic drugs (ANDA) | October 31, 2024 |
| Bausch & Lomb Incorporated | 7 | solution; solution/ drops | New drug applications (NDA) | February 17, 2022 |
| Bausch & Lomb Americas Inc. | 6 | solution; solution/ drops | Authorized generics (NDA) | June 23, 2022 |
| A-S Medication Solutions | 4 | solution; solution/ drops | Generic drugs (ANDA) | September 16, 2024 |
| Lifestar Pharma LLC | 4 | solution/ drops | Generic drugs (ANDA) | June 26, 2023 |
| Sandoz Inc | 4 | solution; solution, gel forming / drops | Generic drugs (ANDA) | December 24, 1998 |
| Caplin Steriles Limited | 3 | solution | Generic drugs (ANDA) | September 16, 2024 |
| Rising Pharma Holdings, Inc. | 3 | tablet | Generic drugs (ANDA) | December 10, 2024 |
| First Nation Group, LLC | 2 | solution/ drops | Generic drugs (ANDA) | May 10, 2024 |
| Ingenus Pharmaceuticals, LLC | 2 | solution/ drops | Generic drugs (ANDA) | September 15, 2022 |
| Pacific Pharma, Inc. | 2 | solution/ drops | Generic drugs (ANDA) | May 20, 1997 |
| Rising Pharma Holdings, Inc. | 2 | solution/ drops | Generic drugs (ANDA) | December 15, 2014 |
| Sagent Pharmaceuticals | 2 | solution, gel forming / drops | Generic drugs (ANDA) | January 15, 2026 |
| Armas Pharmaceuticals Inc. | 1 | solution | Generic drugs (ANDA) | May 8, 2023 |
| Aurobindo Pharma Limited | 1 | solution | Generic drugs (ANDA) | March 23, 2023 |
| Leading Pharma, LLC | 1 | solution | Generic drugs (ANDA) | November 7, 2024 |
| Micro Labs Limited | 1 | solution/ drops | Generic drugs (ANDA) | January 1, 2023 |
| Mylan Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | June 8, 1990 |
| Nordic Pharma, Inc. | 1 | solution | Generic drugs (ANDA) | February 26, 2022 |
| NorthStar RxLLC | 1 | solution/ drops | Generic drugs (ANDA) | December 1, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution/ drops | 24 | 42.9% |
| Solution | 22 | 39.3% |
| Solution, gel forming / drops | 6 | 10.7% |
| Tablet | 4 | 7.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 41 | 73.2% |
| New drug applications (NDA) | 9 | 16.1% |
| Authorized generics (NDA) | 6 | 10.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| beta-Adrenergic Blocker | 56 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.