FDA.reportPublic FDA data

KUVAN 100 MG Oral Tablet

RxCUI
1486691
RxNorm name
KUVAN 100 MG Oral Tablet
Display name
KUVAN 100 MG Oral Tablet
Full name
KUVAN 100 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1486691

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
af38711e-8873-4790-a92d-4d583e23fb89KUVAN 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [Kuvan] [SBD] · Kuvan 100 MG Oral Tablet [SY]379These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral use KUVAN (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 200720240826