icosapent ethyl
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
- icosapent ethyl
- Generic name
- ICOSAPENT ETHYL
- Manufacturer
- Softgel Healthcare Private Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 6f5838cd-4d17-401d-8e2a-652d0e73c1e9
- SPL ID
- dc378404-3406-4fc0-829d-cc8273af1ca0
- Version
- 2
- Effective date
- 2026-07-09
- Source export date
- 2026-09-28
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:40:16
| Harmonized routes |
|---|
| ORAL |
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 | 217656 | derived:openfda.application_number |
| application number | ANDA217656 | openfda.application_number | |
| brand name | icosapent ethyl | openfda.brand_name | |
| generic name | ICOSAPENT ETHYL | openfda.generic_name | |
| manufacturer name | Softgel Healthcare Private Limited | openfda.manufacturer_name | |
| ndc | package | 35916-1592-1 | openfda.package_ndc |
| ndc | package | 35916-1738-1 | openfda.package_ndc |
| ndc | product | 35916-1738 | openfda.product_ndc |
| ndc | product | 35916-1592 | openfda.product_ndc |
| ndc11 | package | 35916173801 | derived:openfda.package_ndc |
| ndc11 | package | 35916159201 | derived:openfda.package_ndc |
| rxcui | 1304979 | openfda.rxcui | |
| rxcui | 1811180 | openfda.rxcui | |
| spl id | dc378404-3406-4fc0-829d-cc8273af1ca0 | id | |
| spl set id | 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | set_id | |
| unii | 6GC8A4PAYH | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.