Efudex
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
- Efudex
- Generic name
- FLUOROURACIL
- Manufacturer
- Bausch Health US, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 35de1c1c-bef5-46c5-b6f8-ea032147411c
- SPL ID
- 3375c5f7-9b6f-8ca1-e063-6394a90aaff8
- Version
- 20
- Effective date
- 2025-04-23
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:04:56
| Harmonized routes |
|---|
| TOPICAL |
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 | 016831 | derived:openfda.application_number |
| application number | NDA016831 | openfda.application_number | |
| brand name | Efudex | openfda.brand_name | |
| generic name | FLUOROURACIL | openfda.generic_name | |
| manufacturer name | Bausch Health US, LLC | openfda.manufacturer_name | |
| ndc | package | 0187-3203-02 | openfda.package_ndc |
| ndc | package | 0187-3202-02 | openfda.package_ndc |
| ndc | package | 0187-3202-10 | openfda.package_ndc |
| ndc | package | 0187-3203-10 | openfda.package_ndc |
| ndc | package | 0187-3204-47 | openfda.package_ndc |
| ndc | product | 0187-3204 | openfda.product_ndc |
| ndc | product | 0187-3202 | openfda.product_ndc |
| ndc | product | 0187-3203 | openfda.product_ndc |
| ndc11 | package | 00187320310 | derived:openfda.package_ndc |
| ndc11 | package | 00187320302 | derived:openfda.package_ndc |
| ndc11 | package | 00187320210 | derived:openfda.package_ndc |
| ndc11 | package | 00187320202 | derived:openfda.package_ndc |
| ndc11 | package | 00187320447 | derived:openfda.package_ndc |
| rxcui | 105583 | openfda.rxcui | |
| rxcui | 213045 | openfda.rxcui | |
| spl id | 3375c5f7-9b6f-8ca1-e063-6394a90aaff8 | id | |
| spl set id | 35de1c1c-bef5-46c5-b6f8-ea032147411c | set_id | |
| unii | U3P01618RT | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.