Drug
Who makes azelastine hydrochloride?
12 companies list azelastine hydrochloride as a human prescription drug. Forms: solution/ drops; spray, metered. Routes: intraocular, nasal, ophthalmic.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing azelastine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | solution/ drops; spray, metered | ANDAANDA078738, ANDA090423 | 2 | 13 |
| Apotex Inc.Canada | solution/ drops; spray, metered | ANDAANDA077954, ANDA078621 | 2 | 6 |
| International Medication Systems, Ltd.United States | spray, metered | ANDAANDA077954, ANDA212289 | 2 | 3 |
| Preferred Pharmaceuticals Inc.United States | spray, metered | ANDAANDA077954, ANDA212289 | 2 | 1 |
| Alembic Pharmaceuticals LimitedIndia | solution/ drops | ANDAANDA209620 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | spray, metered | ANDAANDA212289 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | solution/ drops | ANDAANDA202305 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | solution/ drops | ANDAANDA210092 | 1 | 4 |
| Proficient Rx LPUnited States | spray, metered | ANDAANDA077954 | 1 | 1 |
| Somerset Therapeutics Private LimitedIndia | solution/ drops | ANDAANDA207411 | 1 | 1 |
| Fosun Pharma USA Inc. | solution/ drops | ANDAANDA210092 | 1 | 0 |
| Northstar Rx, LLC, | spray, metered | ANDAANDA212289 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Coral Drugs Private LimitedIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Daito Pharmaceutical Co., LtdJapan · 1 NDC
- Esteve Quimica, S.A.Spain · 1 NDC
- Evonik Operations GmbHGermany · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Urquima, S.A.Spain · 1 NDC
- ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.China · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists azelastine hydrochloride as the active ingredient, expiring between Jun 2028 and Jun 2028. Application holders: BAYER HEALTHCARE CONSUMER CARE, VIATRIS SPECIALTY LLC.
Enquiry
Common questions
- Who makes azelastine hydrochloride?
- 12 companies list azelastine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Apotex Inc., International Medication Systems, Ltd., Preferred Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic azelastine hydrochloride?
- 12 companies list azelastine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies azelastine hydrochloride active ingredient?
- 11 companies list azelastine hydrochloride as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Coral Drugs Private Limited, Curia India Private Limited, Daito Pharmaceutical Co., Ltd.