warnings
WARNINGS Azelastine hydrochloride ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.
Azelastine Hydrochloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Azelastine Hydrochloride
- Generic name
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Gland Pharma Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- f358cecd-284f-4d0b-806c-039465220bd2
- SPL ID
- a29e9f18-dc8f-491a-b502-e26c0d8bfe08
- Version
- 5
- Effective date
- 2025-10-22
- Source export date
- 2026-10-30
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:46:53
| Harmonized routes |
|---|
| INTRAOCULAR |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 210092 | derived:openfda.application_number |
| application number | ANDA210092 | openfda.application_number | |
| brand name | Azelastine Hydrochloride | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Gland Pharma Limited | openfda.manufacturer_name | |
| ndc | package | 68083-287-01 | openfda.package_ndc |
| ndc | product | 68083-287 | openfda.product_ndc |
| ndc11 | package | 68083028701 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | a29e9f18-dc8f-491a-b502-e26c0d8bfe08 | id | |
| spl set id | f358cecd-284f-4d0b-806c-039465220bd2 | set_id | |
| unii | 0L591QR10I | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1 to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied. To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.