roflumilast 0.5 MG Oral Tablet
- RxCUI
- 1091839
- RxNorm name
- roflumilast 0.5 MG Oral Tablet
- Display name
- roflumilast 0.5 MG Oral Tablet
- Full name
- roflumilast 0.5 MG Oral Tablet
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:29
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Roflumilast | ROFLUMILAST | Jubilant Cadista Pharmaceuticals Inc. | aaa81c1b-f63d-4e61-8bfa-9d42d92043c7 | 2026-07-14 | Warnings, Adverse reactions | 1091839 |
| roflumilast | ROFLUMILAST | AvKARE | 55009549-3f0c-1f58-e063-6294a90a6c03 | 2026-06-24 | Warnings, Adverse reactions | 1091839 |
| ROFLUMILAST | ROFLUMILAST | Amici Pharma Inc. | cb3781ff-5350-4f9a-b247-0b04eb0f2b92 | 2026-05-19 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Major Pharmaceuticals | ca22f3e0-6f33-4f1c-97e5-0c962891067a | 2025-12-10 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | MAJOR PHARMACEUTICALS | c51b80f3-a591-4db9-81b4-b91603e35d7c | 2025-12-04 | Warnings, Adverse reactions | 1091839 |
| ROFLUMILAST | ROFLUMILAST | Micro Labs Limited | dc2a689f-cfa4-4863-9623-a9813dcf86a9 | 2025-07-24 | Warnings, Adverse reactions | 1091839 |
| ROFLUMILAST | ROFLUMILAST | Aurobindo Pharma Limited | 7cb11d48-6bb9-437b-bc7f-382050a2d3e6 | 2025-05-27 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Golden State Medical Supply, Inc. | 30dd6eae-6435-cae1-e063-6294a90a003b | 2025-03-21 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Ascend Laboratories, LLC | 93d72a99-64dc-4fde-a5b8-78331fa60787 | 2025-03-13 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | American Health Packaging | 913f1b95-9c46-40d5-a6e9-cff2e5e07eaa | 2024-11-21 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Novadoz Pharmaceuticals LLC | 4d25f69c-58b7-4e2a-b835-4d0c76a83c7c | 2024-08-27 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Zydus Pharmaceuticals USA Inc. | 84145572-f320-4c3f-ab29-bd9f6c18746c | 2024-08-16 | Warnings, Adverse reactions | 1091839 |
| ROFLUMILAST | ROFLUMILAST | Bryant Ranch Prepack | fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72 | 2024-08-15 | Warnings, Adverse reactions | 1091839 |
| Roflumilast | ROFLUMILAST | Zydus Lifesciences Limited | e87287bd-eae3-46c3-9072-04800aeabf40 | 2024-08-12 | 1091839 | |
| Roflumilast | ROFLUMILAST | Camber Pharmaceuticals, Inc. | f25a0230-3cf6-4366-bebe-0ea5ff8de5ab | 2023-04-28 | Warnings, Adverse reactions | 1091839 |
| ROFLUMILAST | ROFLUMILAST | Solco Healthcare US, LLC. | 4251c764-7224-4f94-9de7-b6c76cb1f5cd | 2022-05-10 | Warnings, Adverse reactions | 1091839 |
| Daliresp | ROFLUMILAST | AstraZeneca Pharmaceuticals LP | c9a1d0a8-581f-4f91-a2b8-f419192d0ebf | 2020-03-12 | Warnings, Adverse reactions | 1091839 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 100 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20240815 |
| c9a1d0a8-581f-4f91-a2b8-f419192d0ebf | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 15 | These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP. DALIRESP ® (roflumilast) tablets Initial U.S. Approval: 2011 | 20200312 |
| 78d2644d-b62c-48f5-8407-2adf09bcb144 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 8 | These highlights do not include all the information needed to use ROFLUMILAST tablets safely and effectively. See full prescribing information for ROFLUMILAST tablets. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20260109 |
| dc2a689f-cfa4-4863-9623-a9813dcf86a9 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20250724 |
| 7cb11d48-6bb9-437b-bc7f-382050a2d3e6 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20250527 |
| ca22f3e0-6f33-4f1c-97e5-0c962891067a | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20251210 |
| 93d72a99-64dc-4fde-a5b8-78331fa60787 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20250313 |
| c51b80f3-a591-4db9-81b4-b91603e35d7c | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20251204 |
| e87287bd-eae3-46c3-9072-04800aeabf40 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 4 | Roflumilast Tablets, for oral use | 20240812 |
| 4d25f69c-58b7-4e2a-b835-4d0c76a83c7c | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20240827 |
| 84145572-f320-4c3f-ab29-bd9f6c18746c | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20240816 |
| cb3781ff-5350-4f9a-b247-0b04eb0f2b92 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20260519 |
| 913f1b95-9c46-40d5-a6e9-cff2e5e07eaa | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20241121 |
| f25a0230-3cf6-4366-bebe-0ea5ff8de5ab | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20230428 |
| aaa81c1b-f63d-4e61-8bfa-9d42d92043c7 | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 1 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20260209 |
| 30dd6eae-6435-cae1-e063-6294a90a003b | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 1 | ROFLUMILAST TABLETS. These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | 20250321 |
| 4251c764-7224-4f94-9de7-b6c76cb1f5cd | roflumilast 500 MCG Oral Tablet [PSN] · roflumilast 0.5 MG Oral Tablet [SCD] · roflumilast 500 MCG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use ROFLUMILAST safely and effectively. See full prescribing information for ROFLUMILAST. ROFLUMILAST (roflumilast) TABLET for ORAL use. Initial U.S. Approval: 2011 | 20220510 |