warnings
WARNINGS
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product 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 | 204097 | derived:openfda.application_number |
| application number | ANDA204097 | openfda.application_number | |
| brand name | Fexofenadine HCL | openfda.brand_name | |
| generic name | FEXOFENADINE HCL | openfda.generic_name | |
| manufacturer name | NorthStar RxLLC | openfda.manufacturer_name | |
| ndc | package | 16714-899-02 | openfda.package_ndc |
| ndc | package | 16714-899-01 | openfda.package_ndc |
| ndc | product | 16714-899 | openfda.product_ndc |
| ndc11 | package | 16714089902 | derived:openfda.package_ndc |
| ndc11 | package | 16714089901 | derived:openfda.package_ndc |
| rxcui | 997420 | openfda.rxcui | |
| spl id | 2d00700d-63a2-4a45-b607-028a883fe10a | id | |
| spl set id | 9c308a91-640d-441b-8fb5-acb5a415405e | set_id | |
| unii | 2S068B75ZU | openfda.unii |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse event summaries are temporarily unavailable. Other product information remains available.