warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.
Verified complete openFDA source JSON
| Harmonized routes |
|---|
| ORAL |
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 | 204507 | derived:openfda.application_number |
| application number | ANDA204507 | openfda.application_number | |
| brand name | Fexofenadine Hydrochloride | openfda.brand_name | |
| generic name | FEXOFENADINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | NUVICARE LLC | openfda.manufacturer_name | |
| ndc | package | 84324-045-01 | openfda.package_ndc |
| ndc | product | 84324-045 | openfda.product_ndc |
| ndc11 | package | 84324004501 | derived:openfda.package_ndc |
| spl id | 9af9c85f-e9d5-45f1-aaa8-488af705b2cc | id | |
| spl set id | dd0da52b-fc82-4ec9-854c-0d7c52e926fb | set_id | |
| unii | 2S068B75ZU | openfda.unii |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.