warnings
WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use.
Azelastine Hydrochloride Ophthalmic Solution 0.05%
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 Ophthalmic Solution 0.05%
- Generic name
- AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05%
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7532ed82-5cfa-49da-83e5-c57ffdd3adbb
- SPL ID
- 0857a4e2-caec-4c87-9894-949a549144c3
- Version
- 7
- Effective date
- 2025-01-02
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:36:52
| Harmonized routes |
|---|
| OPHTHALMIC |
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 | 209620 | derived:openfda.application_number |
| application number | ANDA209620 | openfda.application_number | |
| brand name | Azelastine Hydrochloride Ophthalmic Solution 0.05% | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05% | openfda.generic_name | |
| manufacturer name | Alembic Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 62332-506-06 | openfda.package_ndc |
| ndc | product | 62332-506 | openfda.product_ndc |
| ndc11 | package | 62332050606 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | 0857a4e2-caec-4c87-9894-949a549144c3 | id | |
| spl set id | 7532ed82-5cfa-49da-83e5-c57ffdd3adbb | set_id | |
| unii | 0L591QR10I | openfda.unii |
Warnings cross-check#
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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 1–10% 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.