Data / Drug companies / Hydroxyzine hydrochloride
Hydroxyzine hydrochloride: 51 companies and 191 products in the FDA NDC directory
Hydroxyzine hydrochloride is listed in the FDA National Drug Code Directory by 51 companies, with 191 products in commercial distribution. 191 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; tablet; solution, and the newest product started marketing on September 11, 2026.
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- Companies listing it
- 51
- Products
- 191
- Generic (ANDA) products
- 191 (100.0%)
- Application numbers
- 25
- Routes
- Oral, Intramuscular
- openFDA record search
- api.fda.gov
Companies that list hydroxyzine 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 | 23 | tablet, film coated; tablet | Generic drugs (ANDA) | August 22, 2023 |
| Bryant Ranch Prepack | 17 | tablet, film coated; tablet | Generic drugs (ANDA) | August 22, 2023 |
| NuCare Pharmaceuticals,Inc. | 10 | tablet, film coated; tablet | Generic drugs (ANDA) | August 22, 2023 |
| Remedyrepack Inc. | 10 | tablet; tablet, film coated | Generic drugs (ANDA) | June 16, 2025 |
| Chartwell RX, LLC | 9 | tablet, film coated; tablet | Generic drugs (ANDA) | August 20, 2014 |
| PD-Rx Pharmaceuticals, Inc. | 8 | tablet, film coated; tablet | Generic drugs (ANDA) | August 20, 2014 |
| Bryant Ranch Prepack | 6 | tablet, film coated | Generic drugs (ANDA) | October 7, 2021 |
| Northwind Health Company, LLC | 5 | tablet; tablet, film coated | Generic drugs (ANDA) | August 16, 2022 |
| Preferred Pharmaceuticals Inc. | 5 | tablet, film coated; tablet | Generic drugs (ANDA) | May 1, 2025 |
| Proficient Rx LP | 5 | tablet, film coated; tablet | Generic drugs (ANDA) | March 31, 2015 |
| Advanced Rx of Tennessee, LLC | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | July 10, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 4 | tablet; tablet, film coated | Generic drugs (ANDA) | August 1, 2023 |
| Bryant Ranch Prepack | 4 | tablet, film coated | Generic drugs (ANDA) | August 20, 2014 |
| Coupler LLC | 4 | tablet; tablet, film coated | Generic drugs (ANDA) | August 31, 2026 |
| PD-Rx Pharmaceuticals, Inc. | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | August 20, 2014 |
| American Health Packaging | 3 | tablet, film coated | Generic drugs (ANDA) | September 11, 2025 |
| American Regent, Inc. | 3 | injection, solution | Generic drugs (ANDA) | September 30, 1990 |
| Asclemed USA, Inc. | 3 | tablet | Generic drugs (ANDA) | August 20, 2014 |
| Aurobindo Pharma Limited | 3 | tablet, film coated | Generic drugs (ANDA) | October 7, 2021 |
| Camber Pharmaceuticals, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | May 29, 2008 |
| Epic Pharma, LLC | 3 | tablet, film coated | Generic drugs (ANDA) | March 31, 2015 |
| Golden State Medical Supply, Inc. | 3 | tablet | Generic drugs (ANDA) | August 20, 2014 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 3 | tablet | Generic drugs (ANDA) | August 20, 2014 |
| KVK-Tech, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | July 24, 2012 |
| Marlex Pharmaceuticals, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | March 1, 2025 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 3 | tablet | Generic drugs (ANDA) | August 20, 2014 |
| NorthStar Rx LLC | 3 | tablet | Generic drugs (ANDA) | November 11, 2009 |
| Proficient Rx LP | 3 | tablet; syrup | Generic drugs (ANDA) | August 20, 2014 |
| Puracap Laboratories LLC DBA Blu Pharmaceuticals | 3 | tablet, film coated | Generic drugs (ANDA) | July 21, 2021 |
| Rising Pharma Holdings, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | August 22, 2023 |
| St. Mary's Medical Park Pharmacy | 3 | tablet, film coated | Generic drugs (ANDA) | March 19, 2025 |
| Sunrise Pharmaceutical, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | May 6, 2024 |
| Teva Pharmaceuticals USA, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | February 19, 2013 |
| Major Pharmaceuticals | 2 | tablet | Generic drugs (ANDA) | August 1, 2023 |
| Advagen Pharma Ltd | 1 | solution | Generic drugs (ANDA) | September 11, 2026 |
| Ani Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | January 15, 2026 |
| Apozeal Pharmaceuticals Inc | 1 | solution | Generic drugs (ANDA) | July 16, 2024 |
| Atlantic Biologicals Corp. | 1 | solution | Generic drugs (ANDA) | August 21, 2013 |
| Cardinal Health 107, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | October 22, 2025 |
| Chartwell Governmental & Specialty RX, LLC. | 1 | syrup | Generic drugs (ANDA) | April 12, 1982 |
| Direct_Rx | 1 | tablet | Generic drugs (ANDA) | March 3, 2022 |
| HF Acquisition Co LLC, DBA HealthFirst | 1 | injection, solution | Generic drugs (ANDA) | September 30, 1990 |
| Henry Schein, Inc. | 1 | injection, solution | Generic drugs (ANDA) | January 17, 2022 |
| Kesin Pharma Corporation | 1 | solution | Generic drugs (ANDA) | July 17, 2025 |
| Lannett Company, Inc. | 1 | solution | Generic drugs (ANDA) | August 21, 2013 |
| Medsource Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | August 20, 2014 |
| Pai Holdings, LLC DBA Pai Pharma | 1 | solution | Generic drugs (ANDA) | April 10, 2002 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | August 22, 2023 |
| Redpharm Drug | 1 | tablet | Generic drugs (ANDA) | November 11, 2009 |
| Saptalis Pharmaceuticals, LLC. | 1 | solution | Generic drugs (ANDA) | June 17, 2026 |
| Unit Dose Solutions, Inc. | 1 | tablet | Generic drugs (ANDA) | June 24, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 111 | 58.1% |
| Tablet | 62 | 32.5% |
| Solution | 9 | 4.7% |
| Injection, solution | 5 | 2.6% |
| Syrup | 4 | 2.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 191 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antihistamine | 191 |
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.