Data / Drug companies / Loteprednol etabonate
Loteprednol etabonate: 11 companies and 24 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Loteprednol etabonate is listed in the FDA National Drug Code Directory by 11 companies, with 24 products in commercial distribution. 15 of the products (62.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are suspension/ drops; gel; ointment, and the newest product started marketing on April 17, 2026.
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- Companies listing it
- 11
- Products
- 24
- Generic (ANDA) products
- 15 (62.5%)
- Application numbers
- 15
- Routes
- Ophthalmic
- Brand names
- Lotemax, Alrex, Eysuvis, Lotemax, Lotemax SM
- openFDA record search
- api.fda.gov
Companies that list loteprednol etabonate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bausch & Lomb Incorporated | 5 | suspension/ drops; gel | New drug applications (NDA) | February 25, 2019 |
| Amneal Pharmaceuticals NY LLC | 3 | suspension/ drops | Generic drugs (ANDA) | May 22, 2025 |
| Armas Pharmaceuticals Inc. | 3 | suspension/ drops; gel | Generic drugs (ANDA) | October 26, 2023 |
| Bausch & Lomb Americas Inc. | 3 | suspension/ drops; gel | Authorized generics (NDA) | February 9, 2024 |
| Sentiss Pharmaceuticals LLC | 3 | suspension/ drops; gel | Generic drugs (ANDA) | April 17, 2026 |
| Padagis US LLC | 2 | suspension/ drops | Generic drugs (ANDA) | March 31, 2026 |
| Alcon Laboratories, Inc. | 1 | suspension/ drops | New drug applications (NDA) | November 18, 2020 |
| Lupin Pharmaceuticals, Inc. | 1 | suspension | Generic drugs (ANDA) | July 15, 2025 |
| NorthStar RxLLC | 1 | suspension/ drops | Generic drugs (ANDA) | September 1, 2024 |
| Sportpharm LLC | 1 | suspension/ drops | Generic drugs (ANDA) | October 24, 2023 |
| Sun Pharmaceutical Industries, Inc. | 1 | suspension/ drops | Generic drugs (ANDA) | May 1, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Suspension/ drops | 17 | 70.8% |
| Gel | 5 | 20.8% |
| Ointment | 1 | 4.2% |
| Suspension | 1 | 4.2% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 15 | 62.5% |
| New drug applications (NDA) | 6 | 25% |
| Authorized generics (NDA) | 3 | 12.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Corticosteroid | 24 |
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.