Data / Drug companies / Azelastine hydrochloride
Azelastine hydrochloride: 17 companies and 22 products in the FDA NDC directory
Azelastine hydrochloride is listed in the FDA National Drug Code Directory by 17 companies, with 22 products in commercial distribution. 22 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are spray, metered; solution/ drops, and the newest product started marketing on July 14, 2026.
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- Companies listing it
- 17
- Products
- 22
- Generic (ANDA) products
- 22 (100.0%)
- Application numbers
- 11
- Routes
- Nasal, Intraocular, Ophthalmic
- openFDA record search
- api.fda.gov
Companies that list azelastine 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 | 2 | spray, metered | Generic drugs (ANDA) | May 8, 2020 |
| Allegiant Health | 2 | spray, metered | Generic drugs (ANDA) | May 2, 2025 |
| Apotex Corp. | 2 | solution/ drops; spray, metered | Generic drugs (ANDA) | March 1, 2010 |
| Preferred Pharmaceuticals Inc. | 2 | spray, metered | Generic drugs (ANDA) | November 17, 2025 |
| Sun Pharmaceutical Industries, Inc. | 2 | solution/ drops; spray, metered | Generic drugs (ANDA) | May 24, 2012 |
| Alembic Pharmaceuticals Limited | 1 | solution/ drops | Generic drugs (ANDA) | March 20, 2019 |
| Aurobindo Pharma Limited | 1 | spray, metered | Generic drugs (ANDA) | May 8, 2020 |
| Aurohealth LLC | 1 | spray, metered | Generic drugs (ANDA) | January 27, 2025 |
| CVS Woonsocket Prescription Center, Incorporated | 1 | spray, metered | Generic drugs (ANDA) | August 1, 2025 |
| Fosun Pharma USA Inc. | 1 | solution/ drops | Generic drugs (ANDA) | September 8, 2020 |
| Gland Pharma Limited | 1 | solution/ drops | Generic drugs (ANDA) | February 25, 2020 |
| NorthStar RxLLC | 1 | spray, metered | Generic drugs (ANDA) | July 1, 2025 |
| Proficient Rx LP | 1 | spray, metered | Generic drugs (ANDA) | March 1, 2010 |
| Sandoz Inc | 1 | solution/ drops | Generic drugs (ANDA) | March 21, 2013 |
| Somerset Therapeutics, LLC | 1 | solution/ drops | Generic drugs (ANDA) | April 8, 2019 |
| Walgreen Company | 1 | spray, metered | Generic drugs (ANDA) | July 1, 2025 |
| Yyba Corp | 1 | spray, metered | Generic drugs (ANDA) | July 14, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Spray, metered | 15 | 68.2% |
| Solution/ drops | 7 | 31.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 22 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Histamine-1 Receptor Antagonist | 22 |
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.