FDA.reportPublic FDA data

sapropterin dihydrochloride 500 MG Powder for Oral Solution

RxCUI
1653217
RxNorm name
sapropterin dihydrochloride 500 MG Powder for Oral Solution
Display name
sapropterin dihydrochloride 500 MG Powder for Oral Solution
Full name
sapropterin dihydrochloride 500 MG Powder for Oral Solution
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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1653217
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.3f0d6820-ff59-40c0-882f-aeea2dd1d1ad2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1653217
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 1653217
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEMicro Labs Limited907e24c4-3337-4aee-b789-276e37a85cd82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 1653217
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1653217
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inceecdd8c7-5f8a-0af1-793a-db2e2ba0f4912024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1653217
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1653217
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCb3999f74-920d-4444-afa7-f4211e4eb4312024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1653217

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
af38711e-8873-4790-a92d-4d583e23fb89sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]279These 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
2e13a3b5-e4df-4d5c-9b26-02a7006a7c3esapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]224These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION . SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 200720260428
eecdd8c7-5f8a-0af1-793a-db2e2ba0f491sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]24These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR™ (sapropterin dihydrochloride) powder for oral solution. Initial U.S. Approval: 200720241022
3f0d6820-ff59-40c0-882f-aeea2dd1d1adsapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]23These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 200720260305
b3999f74-920d-4444-afa7-f4211e4eb431sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]23These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 200720240709
39f1d020-4359-401b-88a8-ed25eaa40b45sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]22These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 200720260218
907e24c4-3337-4aee-b789-276e37a85cd8sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]21These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder, for oral solution Initial U.S. Approval: 200720260114
8de84882-dd24-46f2-8416-5e492d4275d1sapropterin dihydrochloride 500 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 500 MG Powder for Oral Solution [SCD]21These 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