FDA.reportPublic FDA data

Harvoni 90 MG / 400 MG Oral Tablet

RxCUI
1591949
RxNorm name
Harvoni 90 MG / 400 MG Oral Tablet
Display name
Harvoni 90 MG / 400 MG Oral Tablet
Full name
Harvoni 90 MG / 400 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HarvoniLEDIPASVIR AND SOFOSBUVIRGilead Sciences, Incf4ec77e4-bae8-4db0-b3d5-bde09c5fa0752024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1591949

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f4ec77e4-bae8-4db0-b3d5-bde09c5fa075Harvoni 90 MG / 400 MG Oral Tablet [PSN] · ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [Harvoni] [SBD] · Harvoni (ledipasvir 90 MG / sofosbuvir 400 MG) Oral Tablet [SY]317These 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: 201420241226
1a1c555d-2fdf-4150-8ace-dbc770c226bfHarvoni 90 MG / 400 MG Oral Tablet [PSN] · ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [Harvoni] [SBD] · Harvoni (ledipasvir 90 MG / sofosbuvir 400 MG) Oral Tablet [SY]310These 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: 201420250616