warnings
WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular 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
- Alembic Pharmaceuticals Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 753d7a69-b0da-4350-9dc5-97f26ebe5cc0
- SPL ID
- 753d7a69-b0da-4350-9dc5-97f26ebe5cc0
- Version
- 1
- Effective date
- 2025-01-02
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:27:50
| 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 | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Alembic Pharmaceuticals Limited | openfda.manufacturer_name | |
| ndc | package | 46708-506-06 | openfda.package_ndc |
| ndc | product | 46708-506 | openfda.product_ndc |
| ndc11 | package | 46708050606 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | 753d7a69-b0da-4350-9dc5-97f26ebe5cc0 | id | |
| spl set id | 753d7a69-b0da-4350-9dc5-97f26ebe5cc0 | set_id | |
| unii | 0L591QR10I | openfda.unii |
Warnings cross-check#
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Adverse reactions cross-check#
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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.