ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
- RxCUI
- 1591943
- RxNorm name
- ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
- Display name
- ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
- Full name
- ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:28
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 |
|---|---|---|---|---|---|---|
| Ledipasvir and Sofosbuvir | LEDIPASVIR AND SOFOSBUVIR | Asegua Therapeutics LLC | 46f4a73b-0cd6-4902-9092-3ac79e882c1a | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | 1591943 |
| Harvoni | LEDIPASVIR AND SOFOSBUVIR | Gilead Sciences, Inc | f4ec77e4-bae8-4db0-b3d5-bde09c5fa075 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 1591943 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| f4ec77e4-bae8-4db0-b3d5-bde09c5fa075 | ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [PSN] · ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [SCD] | 2 | 17 | These highlights do not include all the information needed to use HARVONI ® safely and effectively. See full prescribing information for HARVONI. HARVONI ® (ledipasvir and sofosbuvir) tablets, for oral use HARVONI ® (ledipasvir and sofosbuvir) oral pellets Initial U.S. Approval: 2014 | 20241226 |
| 1a1c555d-2fdf-4150-8ace-dbc770c226bf | ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [PSN] · ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [SCD] | 2 | 10 | These highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014 | 20250616 |
| 46f4a73b-0cd6-4902-9092-3ac79e882c1a | ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [PSN] · ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [SCD] | 2 | 8 | These highlights do not include all the information needed to use LEDIPASVIR and SOFOSBUVIR TABLETS safely and effectively. See full prescribing information for LEDIPASVIR and SOFOSBUVIR TABLETS. LEDIPASVIR and SOFOSBUVIR tablets, for oral use, 90 mg/400 mg (Authorized generic of HARVONI ® ) Initial U.S. Approval: 2014 | 20250110 |