Data / Drug companies / Duloxetine hydrochloride
Duloxetine hydrochloride: 18 companies and 53 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Duloxetine hydrochloride is listed in the FDA National Drug Code Directory by 18 companies, with 53 products in commercial distribution. 53 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, delayed release pellets; capsule, delayed release, and the newest product started marketing on January 1, 2024.
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- Companies listing it
- 18
- Products
- 53
- Generic (ANDA) products
- 53 (100.0%)
- Application numbers
- 5
- Routes
- Oral
- Brand names
- Duloxetine Delayed-Release, Duloxetine, Duloxetine Delayed-Release
- openFDA record search
- api.fda.gov
Companies that list duloxetine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 6 | capsule, delayed release pellets; capsule, delayed release | Generic drugs (ANDA) | June 11, 2014 |
| Bryant Ranch Prepack | 5 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| Proficient Rx LP | 5 | capsule, delayed release pellets; capsule, delayed release | Generic drugs (ANDA) | June 11, 2014 |
| Breckenridge Pharmaceutical, Inc. | 4 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| Bryant Ranch Prepack | 4 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| Quallent Pharmaceuticals Health LLC | 4 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| Aurobindo Pharma Limited | 3 | capsule, delayed release | Generic drugs (ANDA) | December 11, 2013 |
| Bryant Ranch Prepack | 3 | capsule, delayed release pellets | Generic drugs (ANDA) | June 11, 2014 |
| Golden State Medical Supply, Inc. | 3 | capsule, delayed release pellets | Generic drugs (ANDA) | June 11, 2014 |
| Macleods Pharmaceuticals Limited | 3 | capsule, delayed release | Generic drugs (ANDA) | March 24, 2017 |
| Marksans Pharma Limited | 3 | capsule, delayed release | Generic drugs (ANDA) | May 27, 2022 |
| Yaopharma Co., Ltd. | 3 | capsule, delayed release pellets | Generic drugs (ANDA) | January 1, 2024 |
| Preferred Pharmaceuticals Inc. | 2 | capsule, delayed release pellets | Generic drugs (ANDA) | February 1, 2023 |
| A-S Medication Solutions | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | June 11, 2014 |
| BluePoint Laboratories | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| NuCare Pharmaceuticals,Inc. | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | June 11, 2014 |
| Proficient Rx LP | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | May 21, 2018 |
| Remedyrepack Inc. | 1 | capsule, delayed release pellets | Generic drugs (ANDA) | January 13, 2017 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, delayed release pellets | 40 | 75.5% |
| Capsule, delayed release | 13 | 24.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 53 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Serotonin and Norepinephrine Reuptake Inhibitor | 53 |
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.