warnings
Warnings Allergy alert: do not use if you are allergic to omeprazole
Leader Omeprazole
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
- Leader Omeprazole
- Generic name
- OMEPRAZOLE
- Manufacturer
- Cardinal Health 110, LLC. dba Leader
- Product type
- HUMAN OTC DRUG
- SPL set ID
- b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a
- SPL ID
- 867caf67-b128-4c09-9e35-352f8c04bcbe
- Version
- 6
- Effective date
- 2024-11-26
- Source export date
- 2026-10-30
- 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/2026-10-30/a900515c00f4d0d29f88cc94ee68daf127f036296f87a6b4a8a3f964cd0433c0/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:45:21
| 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 | NDA | 209400 | derived:openfda.application_number |
| application number | NDA209400 | openfda.application_number | |
| brand name | Leader Omeprazole | openfda.brand_name | |
| generic name | OMEPRAZOLE | openfda.generic_name | |
| manufacturer name | Cardinal Health 110, LLC. dba Leader | openfda.manufacturer_name | |
| ndc | package | 70000-0381-1 | openfda.package_ndc |
| ndc | package | 70000-0381-2 | openfda.package_ndc |
| ndc | product | 70000-0381 | openfda.product_ndc |
| ndc11 | package | 70000038101 | derived:openfda.package_ndc |
| ndc11 | package | 70000038102 | derived:openfda.package_ndc |
| rxcui | 2003656 | openfda.rxcui | |
| spl id | 867caf67-b128-4c09-9e35-352f8c04bcbe | id | |
| spl set id | b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a | set_id | |
| unii | KG60484QX9 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.