FDA.reportPublic FDA data

probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah]

RxCUI
2717850
RxNorm name
probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah]
Display name
probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah]
Full name
probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

RxNav Current And Historical NDCs#

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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
ORLYNVAHSULOPENEM ETZADROXIL AND PROBENECIDITERUM THERAPEUTICS US LIMITED24c451c0-4cfb-37f3-e063-6394a90a895e2025-12-06Warnings, Adverse reactionsExact identifier
rxcui: 2717850

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
24c451c0-4cfb-37f3-e063-6394a90a895eOrlynvah 500 MG / 500 MG Oral Tablet [PSN] · probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah] [SBD] · Orlynvah (probenecid 500 MG / sulopenem etzadroxil 500 MG) Oral Tablet [SY]36These highlights do not include all the information needed to use ORLYNVAH TM safely and effectively. See full prescribing information for ORLYNVAH TM . ORLYNVAH TM (sulopenem etzadroxil and probenecid) tablets, for oral use Initial U.S. Approval: 202420251206