Quick answers
- What is Azelastine hydrochloride used for?
- The FDA-approved label (Azelastine Hydrochloride, Apotex Corp., September 8, 2026) says: “Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azelastine hydrochloride have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Azelastine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Azelastine hydrochloride been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 28, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Azelastine hydrochloride?
- 16 companies list prescription products of Azelastine hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Sun Pharmaceutical Industries, Inc. and Preferred Pharmaceuticals Inc..
What Azelastine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. …
— FDA label: Azelastine Hydrochloride, Apotex Corp., effective September 8, 2026. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Spray, metered · Solution/ drops |
|---|---|
| Route | Nasal · Intraocular · Ophthalmic |
| Prescription products | 20 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| azelastine hydrochloride 0.5 mg/mL solution/ drops | Generic | $0.9726 per mL |
| azelastine hydrochloride 1 mg/mL spray, metered | Generic | $0.2662 per mL |
| azelastine hydrochloride 137 ug spray, metered | Generic | $0.2662 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Apotex Corp.2 products
- Aurobindo Pharma Limited1 product
- AvKARE1 product
- Alembic Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Somerset Therapeutics, LLC1 product
- Sandoz Inc1 product
- Gland Pharma Limited1 product
- Proficient Rx LP1 product
- Fosun Pharma USA Inc.1 product
- Ascend Laboratories, LLC1 product
- NorthStar Rx LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA077954Apotex Inc · April 30, 2009
- ANDA078621Apotex · August 3, 2009
- ANDA078738Sun Pharm · June 21, 2010
- ANDA090423Sun Pharm · May 23, 2012
- ANDA202305Sandoz · May 31, 2012
- ANDA208156Alkem Labs Ltd · August 18, 2017
- ANDA204660Amneal · August 28, 2017
- ANDA209620Alembic · March 20, 2019
- ANDA207411Somerset Theraps LLC · March 29, 2019
- ANDA210092Gland · February 25, 2020
- ANDA212289Aurobindo Pharma Ltd · May 8, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 28, 2025 · Class II · Ongoing · D-0495-2025
Lack of Assurance of Sterility
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 — Apotex Corp.
-
February 5, 2018 · Class III · Terminated · D-0417-2018
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Ha — Sun Pharmaceutical Industries, Inc.
-
June 15, 2011 · Class III · Terminated · D-1667-2012
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. — Apotex Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 860805, 1797867 |
|---|---|
| SPL set ID of the quoted label | 4f58c203-f649-a18e-aaf3-70b0797652f4 |
| FDA labels (SPL) | 20 |
| FDA applications | 11 ANDA |
| Active ingredients (FDA) | AZELASTINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azelastine Hydrochloride, Apotex Corp., effective September 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →