warnings
WARNINGS Azelastine hydrochloride ophthalmic solution 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
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 04e5eede-17ff-4765-af77-d46c139da703
- SPL ID
- b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b
- Version
- 4
- Effective date
- 2018-10-24
- Source export date
- 2026-10-27
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:12:25
| 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 | 078738 | derived:openfda.application_number |
| application number | ANDA078738 | openfda.application_number | |
| brand name | Azelastine Hydrochloride | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 47335-938-90 | openfda.package_ndc |
| ndc | product | 47335-938 | openfda.product_ndc |
| ndc11 | package | 47335093890 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b | id | |
| spl set id | 04e5eede-17ff-4765-af77-d46c139da703 | 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 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.