Data / Drug companies / Fluoxetine hydrochloride
Fluoxetine hydrochloride: 44 companies and 129 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Fluoxetine hydrochloride is listed in the FDA National Drug Code Directory by 44 companies, with 129 products in commercial distribution. 126 of the products (97.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; tablet, coated; tablet, film coated, and the newest product started marketing on October 26, 2026.
The request: Get every company that lists fluoxetine hydrochloride in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.
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- Companies listing it
- 44
- Products
- 129
- Generic (ANDA) products
- 126 (97.7%)
- Application numbers
- 16
- Routes
- Oral
- Brand names
- Fluoxetine, Prozac, Fluoxetine
- openFDA record search
- api.fda.gov
Companies that list fluoxetine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 15 | capsule | Generic drugs (ANDA) | September 25, 2019 |
| Bryant Ranch Prepack | 7 | tablet, coated; capsule | Generic drugs (ANDA) | August 22, 2016 |
| Bryant Ranch Prepack | 7 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Northwind Health Company, LLC | 6 | capsule | Generic drugs (ANDA) | October 4, 2022 |
| NuCare Pharmaceuticals,Inc. | 5 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Proficient Rx LP | 5 | capsule | Generic drugs (ANDA) | September 25, 2019 |
| Remedyrepack Inc. | 5 | capsule | Generic drugs (ANDA) | July 31, 2025 |
| ScieGen Pharmaceuticals, Inc. | 5 | capsule; tablet | Generic drugs (ANDA) | September 11, 2025 |
| Coupler LLC | 4 | capsule | Generic drugs (ANDA) | October 26, 2026 |
| NorthStar Rx LLC | 4 | capsule; tablet, film coated | Generic drugs (ANDA) | September 18, 2019 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | January 31, 2008 |
| BluePoint Laboratories | 3 | capsule | Generic drugs (ANDA) | June 19, 2019 |
| Bryant Ranch Prepack | 3 | tablet, coated; capsule | Generic drugs (ANDA) | August 22, 2016 |
| Dista Products Company | 3 | capsule | New drug applications (NDA) | June 15, 1999 |
| Lupin Pharmaceuticals, Inc. | 3 | tablet | Generic drugs (ANDA) | August 7, 2019 |
| Marksans Pharma Limited | 3 | capsule | Generic drugs (ANDA) | January 29, 2022 |
| PD-Rx Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | January 31, 2008 |
| Preferred Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | May 18, 2021 |
| Proficient Rx LP | 3 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Quallent Pharmaceuticals Health LLC | 3 | capsule | Generic drugs (ANDA) | September 1, 2023 |
| Radha Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | October 24, 2022 |
| Strides Pharma Inc. | 3 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Time Cap Laboratories, Inc | 3 | capsule | Generic drugs (ANDA) | February 12, 2022 |
| Alembic Pharmaceuticals Limited | 2 | tablet, film coated | Generic drugs (ANDA) | April 15, 2017 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | capsule | Generic drugs (ANDA) | October 24, 2022 |
| Calvin Scott & Co., Inc. | 2 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Major Pharmaceuticals | 2 | capsule | Generic drugs (ANDA) | January 3, 2025 |
| Pai Holdings, LLC DBA Pai Pharma | 2 | solution | Generic drugs (ANDA) | February 1, 2002 |
| Par Health USA, LLC | 2 | tablet, coated | Generic drugs (ANDA) | August 22, 2016 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | July 21, 2022 |
| Ani Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | November 9, 2022 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| Cardinal Health 107, LLC | 1 | capsule | Generic drugs (ANDA) | December 4, 2024 |
| Direct_Rx | 1 | capsule | Generic drugs (ANDA) | January 7, 2020 |
| Dr. Reddy's Laboratories Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | January 28, 2019 |
| Dr. Reddy's Laboratories Limited | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | March 24, 2010 |
| Lannett Company, Inc. | 1 | liquid | Generic drugs (ANDA) | August 27, 2009 |
| Medsource Pharmaceuticals | 1 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| PD-Rx Pharmaceuticals, Inc. | 1 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| QPharma, Inc. | 1 | capsule | Generic drugs (ANDA) | January 31, 2008 |
| Redpharm Drug | 1 | capsule | Generic drugs (ANDA) | March 16, 2015 |
| St. Mary's Medical Park Pharmacy | 1 | capsule | Generic drugs (ANDA) | June 30, 2020 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | February 15, 2019 |
| Upsher-Smith Laboratories, LLC | 1 | for solution | Generic drugs (ANDA) | November 15, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 104 | 80.6% |
| Tablet, coated | 9 | 7% |
| Tablet, film coated | 5 | 3.9% |
| Tablet | 5 | 3.9% |
| Solution | 3 | 2.3% |
| Liquid | 1 | 0.8% |
| For solution | 1 | 0.8% |
| Capsule, delayed release pellets | 1 | 0.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 126 | 97.7% |
| New drug applications (NDA) | 3 | 2.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Serotonin Reuptake Inhibitor | 129 |
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.