Prescription and over-the-counter medicine
Azelastine Brand names: Astepro; first approved as Astelin
Azelastine (Astepro) is a prescription and over-the-counter medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.273 per mL (Azelastine 0.1% (137 mcg) spry) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the azelastine FDA label on DailyMed (effective December 4, 2025, Bayer HealthCare LLC.); the NDA 20114 record on Drugs@FDA; every azelastine label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Forms and strengths
- 0.5 mg/ml
- 1 mg/ml
Spray (metered); solution/ drops.
On the market
- Earliest approval on file
- November 1, 1996 Astelin, Rising; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first April 30, 2009; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 22 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 4, 2028 Astepro Allergy spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.273 per mL Azelastine 0.1% (137 mcg) spry
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2011 0 Class I among all firms' recalls; latest May 28, 2025
- FAERS reports
- 18,108 through July 30, 2026
What is azelastine used for?
From the label: indications and usageUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Conditions named in the indications of azelastine's FDA labels, with every medicine labeled for each:
From other azelastine labelsAllergies: 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 …
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Astepro Allergy), Bayer HealthCare LLC., effective December 4, 2025 (SPL set e0640846-19a6-7f79-e053-2995a90a8176), via openFDA; the full label on DailyMed
What does the patient leaflet for azelastine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using azelastine hydrochloride nasal spray?Azelastine hydrochloride nasal spray can cause sleepiness: Do not drive, operate machinery, or do other dangerous activities until you know how azelastine hydrochloride nasal spray affects you. Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine hydrochloride nasal spray. It may make your sleepiness worse.
From the patient leaflet: How should I store azelastine hydrochloride nasal spray?Store upright at 20ºC to 25ºC (68ºF to 77ºF) Do not freeze azelastine hydrochloride nasal spray. Do not use azelastine hydrochloride nasal spray after the expiration date "EXP" on the medicine label and box. Keep azelastine hydrochloride nasal spray and all medicines out of reach of children.
Source: FDA drug label (Azelastine Hydrochloride), Apotex Corp., effective September 8, 2026 (SPL set 4f58c203-f649-a18e-aaf3-70b0797652f4), via openFDA; the full label on DailyMed
Is there a generic for azelastine (Astepro)?
The FDA approved the first generic azelastine on April 30, 2009. 27 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists azelastine from 22 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Astepro Allergy spray, the last expiring on June 4, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2009 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for azelastine (Astepro)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.273 per mL (Azelastine 0.1% (137 mcg) spry), down 4% from $0.284 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Azelastine 0.1% (137 mcg) spry (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Azelastine 0.1% (137 mcg) spry | Generic | $0.273 per mL | n/a | -4% |
| Azelastine HCl 0.05% drops | Generic | $1.01 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has azelastine been recalled?
The FDA's Enforcement Report lists 3 recalls naming azelastine since 2011: 0 Class I (the most serious), 1 Class II, 2 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 28, 2025 | Class II | Apotex Corp. | Lack of Assurance of Sterility |
| February 5, 2018 | Class III | Sun Pharmaceutical Industries, Inc. | 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 … |
| June 15, 2011 | Class III | Apotex Corp. | CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for azelastine?
The FDA Adverse Event Reporting System holds 18,108 reports that list azelastine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 555 are coded as a death and 3,060 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as azelastine?
4 other medicines are given the same way (nasal) and in the same FDA class as azelastine or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (nasal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Olopatadine | Allergies | 4 labelers | $0.850 per gram 665 mcg nasal spry | No current entry |
| Mometasone and olopatadine | Allergies | none listed | $7.67 per gram 665-25 mcg spray | No current entry |
| Fluticasone | Allergies | 67 labelers | $0.676 per gram 50 mcg spray | No current entry |
| Mometasone | Allergies | 5 labelers | $1.59 per gram 50 mcg spry | No current entry |
Every medicine labeled for the same conditions as azelastine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does azelastine compare with medicines for the same use?
7 side-by-side pages set azelastine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to azelastine
- 4 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Azelastine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other