FDA.reportPublic FDA data

Harvoni 45 MG / 200 MG per packet Oral Pellets

RxCUI
2204104
RxNorm name
Harvoni 45 MG / 200 MG per packet Oral Pellets
Display name
Harvoni 45 MG / 200 MG per packet Oral Pellets
Full name
Harvoni 45 MG / 200 MG per packet Oral Pellets
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#

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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: 2204104

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-bde09c5fa075Harvoni 45 MG / 200 MG per packet Oral Pellets [PSN] · ledipasvir 45 MG / sofosbuvir 200 MG Oral Pellet [Harvoni] [SBD] · Harvoni (ledipasvir 45 MG / sofosbuvir 200 MG) per packet Oral Pellets [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