Data / Drug companies / Haloperidol decanoate
Haloperidol decanoate: 16 companies and 58 products in the FDA NDC directory
Haloperidol decanoate is listed in the FDA National Drug Code Directory by 16 companies, with 58 products in commercial distribution. 56 of the products (96.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution, and the newest product started marketing on May 29, 2026.
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- Companies listing it
- 16
- Products
- 58
- Generic (ANDA) products
- 56 (96.6%)
- Application numbers
- 10
- Routes
- Intramuscular
- openFDA record search
- api.fda.gov
Companies that list haloperidol decanoate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Somerset Therapeutics, LLC | 9 | injection | Generic drugs (ANDA) | September 29, 2025 |
| BluePoint Laboratories | 8 | injection | Generic drugs (ANDA) | June 12, 2025 |
| Remedyrepack Inc. | 5 | injection; injection, solution | Generic drugs (ANDA) | May 29, 2026 |
| Lifestar Pharma LLC | 4 | injection | Generic drugs (ANDA) | May 23, 2023 |
| Zydus Lifesciences Limited | 4 | injection | Generic drugs (ANDA) | November 14, 2019 |
| Zydus Pharmaceuticals USA Inc. | 4 | injection | Generic drugs (ANDA) | November 14, 2019 |
| Armas Pharmaceuticals Inc. | 3 | injection | Generic drugs (ANDA) | May 15, 2026 |
| Caplin Steriles Limited | 3 | injection | Generic drugs (ANDA) | May 26, 2025 |
| Fresenius Kabi USA, LLC | 3 | injection | Generic drugs (ANDA) | July 12, 2000 |
| Meitheal Pharmaceuticals Inc. | 3 | injection | Generic drugs (ANDA) | July 26, 2021 |
| Sagent Pharmaceuticals | 3 | injection, solution | Generic drugs (ANDA) | November 15, 2017 |
| Gland Pharma Limited | 2 | injection | Generic drugs (ANDA) | January 16, 2017 |
| Hikma Pharmaceuticals USA Inc. | 2 | injection | Generic drugs (ANDA) | October 1, 1998 |
| Mylan Institutional LLC | 2 | injection | Generic drugs (ANDA) | March 1, 2014 |
| Patriot Pharmaceuticals | 2 | injection | Authorized generics (NDA) | June 17, 2011 |
| NorthStar RxLLC | 1 | injection | Generic drugs (ANDA) | December 1, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 54 | 93.1% |
| Injection, solution | 4 | 6.9% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 56 | 96.6% |
| Authorized generics (NDA) | 2 | 3.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Typical Antipsychotic | 58 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.