FDA.reportPublic FDA data

ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet

RxCUI
2204100
RxNorm name
ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet
Display name
ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet
Full name
ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet
Term type
SCD
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: 2204100

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f4ec77e4-bae8-4db0-b3d5-bde09c5fa075ledipasvir 33.75 MG / sofosbuvir 150 MG per packet Oral Pellets [PSN] · ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet [SCD]217These 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