FDA.reportPublic FDA data

Zelvysia 500 MG Powder for Oral Solution

RxCUI
2712691
RxNorm name
Zelvysia 500 MG Powder for Oral Solution
Display name
Zelvysia 500 MG Powder for Oral Solution
Full name
Zelvysia 500 MG Powder for Oral Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

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
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 2712691

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
8de84882-dd24-46f2-8416-5e492d4275d1Zelvysia 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [Zelvysia] [SBD] · Zelvysia 500 MG Powder for Oral Solution [SY]31These highlights do not include all the information needed to use ZELVYSIA safely and effectively. See full prescribing information for ZELVYSIA. ZELVYSIA TM (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 200720250430