Data / Drug companies / Promethazine hydrochloride
Promethazine hydrochloride: 49 companies and 125 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Promethazine hydrochloride is listed in the FDA National Drug Code Directory by 49 companies, with 125 products in commercial distribution. 125 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; suppository, and the newest product started marketing on August 19, 2026.
The request: Get every company that lists promethazine 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
- 49
- Products
- 125
- Generic (ANDA) products
- 125 (100.0%)
- Application numbers
- 17
- Routes
- Oral, Intramuscular, Intravenous, Rectal
- Brand names
- Phenergan, Promethegan
- openFDA record search
- api.fda.gov
Companies that list promethazine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 13 | injection | Generic drugs (ANDA) | September 19, 1973 |
| A-S Medication Solutions | 12 | tablet; suppository | Generic drugs (ANDA) | June 22, 2022 |
| NuCare Pharmaceuticals,Inc. | 6 | tablet | Generic drugs (ANDA) | July 31, 2006 |
| PD-Rx Pharmaceuticals, Inc. | 6 | tablet; suppository | Generic drugs (ANDA) | March 3, 2011 |
| Asclemed USA, Inc. | 5 | tablet; suppository | Generic drugs (ANDA) | June 27, 2006 |
| Northwind Health Company, LLC | 4 | tablet | Generic drugs (ANDA) | October 4, 2023 |
| Amneal Pharmaceuticals LLC | 3 | tablet | Generic drugs (ANDA) | March 3, 2011 |
| Amneal Pharmaceuticals of New York LLC | 3 | tablet | Generic drugs (ANDA) | June 22, 2022 |
| Asclemed USA Inc. | 3 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| BluePoint Laboratories | 3 | tablet | Generic drugs (ANDA) | January 13, 2014 |
| Bryant Ranch Prepack | 3 | tablet | Generic drugs (ANDA) | May 4, 2007 |
| Cosette Pharmaceuticals, Inc. | 3 | suppository | Generic drugs (ANDA) | February 28, 2004 |
| Henry Schein, Inc. | 3 | injection | Generic drugs (ANDA) | January 17, 2022 |
| KVK-Tech, Inc. | 3 | tablet | Generic drugs (ANDA) | May 4, 2007 |
| Proficient Rx LP | 3 | tablet | Generic drugs (ANDA) | January 13, 2014 |
| Remedyrepack Inc. | 3 | tablet | Generic drugs (ANDA) | July 31, 2025 |
| Sportpharm LLC | 3 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| Zydus Lifesciences Limited | 3 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| Zydus Pharmaceuticals USA Inc. | 3 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| Actavis Pharma, Inc. | 2 | tablet | Generic drugs (ANDA) | September 21, 1973 |
| Atlantic Biologicals Corp. | 2 | syrup | Generic drugs (ANDA) | April 7, 2025 |
| Bryant Ranch Prepack | 2 | solution | Generic drugs (ANDA) | February 20, 2024 |
| Camber Pharmaceuticals, Inc. | 2 | suppository | Generic drugs (ANDA) | November 2, 2022 |
| Cardinal Health 107, LLC | 2 | injection; tablet | Generic drugs (ANDA) | July 2, 2024 |
| Coupler LLC | 2 | tablet | Generic drugs (ANDA) | July 6, 2026 |
| Medical Purchasing Solutions, LLC | 2 | injection | Generic drugs (ANDA) | September 19, 1973 |
| Padagis Israel Pharmaceuticals Ltd | 2 | suppository | Generic drugs (ANDA) | June 27, 2006 |
| ProPharma Distribution | 2 | injection; injection, solution | Generic drugs (ANDA) | January 30, 2015 |
| XGen Pharmaceuticals DJB, Inc. | 2 | injection, solution | Generic drugs (ANDA) | January 30, 2015 |
| Advanced Rx of Tennessee, LLC | 1 | tablet | Generic drugs (ANDA) | February 15, 2023 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | June 20, 2022 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | August 30, 2006 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| Chartwell Governmental & Specialty RX, LLC. | 1 | solution | Generic drugs (ANDA) | September 25, 1998 |
| Chartwell RX, LLC | 1 | solution | Generic drugs (ANDA) | September 25, 1998 |
| Cranbury Pharmaceuticals, LLC | 1 | syrup | Generic drugs (ANDA) | June 8, 2012 |
| Direct_Rx | 1 | tablet | Generic drugs (ANDA) | February 9, 2021 |
| Kesin Pharma Corporation | 1 | solution | Generic drugs (ANDA) | December 31, 2024 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | April 17, 2023 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | tablet | Generic drugs (ANDA) | July 2, 2018 |
| Northwind Health Company, LLC | 1 | tablet | Generic drugs (ANDA) | August 19, 2026 |
| PD-Rx Pharmaceuticals, Inc. | 1 | suppository | Generic drugs (ANDA) | February 28, 2002 |
| Pai Holdings, LLC DBA Pai Pharma | 1 | solution | Generic drugs (ANDA) | August 7, 2025 |
| Preferred Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | April 16, 2021 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | September 19, 1973 |
| Quagen Pharmaceuticals LLC | 1 | solution | Generic drugs (ANDA) | July 12, 2021 |
| Redpharm Drug | 1 | tablet | Generic drugs (ANDA) | December 14, 2005 |
| Unit Dose Solutions, Inc. | 1 | tablet | Generic drugs (ANDA) | July 1, 2026 |
| Xttrium Laboratories, Inc. | 1 | syrup | Generic drugs (ANDA) | April 7, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 77 | 61.6% |
| Injection | 21 | 16.8% |
| Suppository | 12 | 9.6% |
| Solution | 7 | 5.6% |
| Syrup | 5 | 4% |
| Injection, solution | 3 | 2.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 125 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Phenothiazine | 125 |
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.