Data / Drug companies / Paroxetine hydrochloride hemihydrate
Paroxetine hydrochloride hemihydrate: 14 companies and 34 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Paroxetine hydrochloride hemihydrate is listed in the FDA National Drug Code Directory by 14 companies, with 34 products in commercial distribution. 34 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, and the newest product started marketing on September 28, 2026.
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- Companies listing it
- 14
- Products
- 34
- Generic (ANDA) products
- 34 (100.0%)
- Application numbers
- 2
- Routes
- Oral
- Brand names
- Paroxetine
- openFDA record search
- api.fda.gov
Companies that list paroxetine hydrochloride hemihydrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Remedyrepack Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | February 25, 2020 |
| Mylan Pharmaceuticals Inc. | 4 | tablet, film coated | Generic drugs (ANDA) | March 24, 2008 |
| Solco Healthcare US, LLC | 4 | tablet, film coated | Generic drugs (ANDA) | March 29, 2022 |
| NuCare Pharmaceuticals,Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | March 29, 2022 |
| Preferred Pharmaceuticals Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | September 28, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | March 24, 2008 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | March 24, 2008 |
| PD-Rx Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | March 24, 2008 |
| PD-Rx Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | March 29, 2022 |
| Proficient Rx LP | 2 | tablet, film coated | Generic drugs (ANDA) | November 1, 2014 |
| A-S Medication Solutions | 1 | tablet, film coated | Generic drugs (ANDA) | November 1, 2014 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | November 1, 2014 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | tablet, film coated | Generic drugs (ANDA) | November 1, 2014 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | November 1, 2014 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 34 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 34 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Serotonin Reuptake Inhibitor | 34 |
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.