FDA.reportPublic FDA data

sapropterin dihydrochloride 100 MG Oral Tablet

RxCUI
1486687
RxNorm name
sapropterin dihydrochloride 100 MG Oral Tablet
Display name
sapropterin dihydrochloride 100 MG Oral Tablet
Full name
sapropterin dihydrochloride 100 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEHikma Pharmaceuticals USA Inc.c4d92cce-e899-4f14-b19c-5e17f99222152026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 1486687
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLCeafec3a2-4f29-4afa-8728-a62b34cefd182026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 1486687
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.ec8ea96c-8ec1-4301-a85d-d59562e548ca2026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 1486687
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEAurobindo Pharma Limited11ee25bc-f501-4f9d-b63d-63b2eee0147e2025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1486687
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCa64a50ba-e3da-4227-9bce-87101d60409e2025-01-06Warnings, Adverse reactionsExact identifier
rxcui: 1486687
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Incd9f3723f-bf7d-9a72-2ef9-41c5508d6ab42024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1486687
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1486687

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
af38711e-8873-4790-a92d-4d583e23fb89sapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble 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
eafec3a2-4f29-4afa-8728-a62b34cefd18sapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]315These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS . SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720260417
ec8ea96c-8ec1-4301-a85d-d59562e548casapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]33These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720260224
a64a50ba-e3da-4227-9bce-87101d60409esapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]33These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720250106
c4d92cce-e899-4f14-b19c-5e17f9922215sapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]32These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720250731
d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4sapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]32These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR TM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 200720241021
11ee25bc-f501-4f9d-b63d-63b2eee0147esapropterin dihydrochloride 100 MG Oral Tablet [PSN] · sapropterin dihydrochloride 100 MG Oral Tablet [SCD] · sapropterin dihydrochloride 100 MG Soluble Tablet [SY]31These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720250610