Roflumilast
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
- Roflumilast
- Generic name
- ROFLUMILAST
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e87287bd-eae3-46c3-9072-04800aeabf40
- SPL ID
- eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
- Version
- 4
- Effective date
- 2024-08-12
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:24:20
| 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 | 208303 | derived:openfda.application_number |
| application number | ANDA208303 | openfda.application_number | |
| brand name | Roflumilast | openfda.brand_name | |
| generic name | ROFLUMILAST | openfda.generic_name | |
| manufacturer name | Zydus Lifesciences Limited | openfda.manufacturer_name | |
| ndc | package | 70771-1674-9 | openfda.package_ndc |
| ndc | package | 70771-1673-3 | openfda.package_ndc |
| ndc | package | 70771-1673-8 | openfda.package_ndc |
| ndc | package | 70771-1673-2 | openfda.package_ndc |
| ndc | package | 70771-1674-3 | openfda.package_ndc |
| ndc | product | 70771-1673 | openfda.product_ndc |
| ndc | product | 70771-1674 | openfda.product_ndc |
| ndc11 | package | 70771167409 | derived:openfda.package_ndc |
| ndc11 | package | 70771167303 | derived:openfda.package_ndc |
| ndc11 | package | 70771167302 | derived:openfda.package_ndc |
| ndc11 | package | 70771167403 | derived:openfda.package_ndc |
| ndc11 | package | 70771167308 | derived:openfda.package_ndc |
| rxcui | 2001319 | openfda.rxcui | |
| rxcui | 1091839 | openfda.rxcui | |
| spl id | eb40db9e-ddc1-4041-aac5-ff0f2c478fc6 | id | |
| spl set id | e87287bd-eae3-46c3-9072-04800aeabf40 | set_id | |
| unii | 0P6C6ZOP5U | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.