Data / Drug companies / Tetracaine hydrochloride
Tetracaine hydrochloride: 9 companies and 11 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Tetracaine hydrochloride is listed in the FDA National Drug Code Directory by 9 companies, with 11 products in commercial distribution. 4 of the products (36.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are solution; solution/ drops, and the newest product started marketing on December 23, 2024.
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- Companies listing it
- 9
- Products
- 11
- Generic (ANDA) products
- 4 (36.4%)
- Application numbers
- 3
- Routes
- Ophthalmic
- openFDA record search
- api.fda.gov
Companies that list tetracaine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Somerset Therapeutics, LLC | 2 | solution | Generic drugs (ANDA) | December 23, 2024 |
| Sportpharm LLC | 2 | solution | Generic drugs (ANDA) | December 23, 2024 |
| A-S Medication Solutions | 1 | solution | New drug applications (NDA) | November 2, 2016 |
| Alcon Laboratories, Inc. | 1 | solution | New drug applications (NDA) | November 2, 2016 |
| Bausch & Lomb Americas Inc. | 1 | solution/ drops | Authorized generics (NDA) | September 21, 2022 |
| Bausch & Lomb Incorporated | 1 | solution/ drops | New drug applications (NDA) | September 23, 2022 |
| Bausch Health US LLC | 1 | solution/ drops | New drug applications (NDA) | June 27, 2019 |
| Oceanside Pharmaceuticals | 1 | solution/ drops | New drug applications (NDA) | June 27, 2019 |
| Remedyrepack Inc. | 1 | solution | New drug applications (NDA) | September 24, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 7 | 63.6% |
| Solution/ drops | 4 | 36.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 6 | 54.5% |
| Generic drugs (ANDA) | 4 | 36.4% |
| Authorized generics (NDA) | 1 | 9.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Ester Local Anesthetic | 11 |
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.