FDA.reportPublic FDA data

sapropterin dihydrochloride 100 MG Powder for Oral Solution

RxCUI
1111018
RxNorm name
sapropterin dihydrochloride 100 MG Powder for Oral Solution
Display name
sapropterin dihydrochloride 100 MG Powder for Oral Solution
Full name
sapropterin dihydrochloride 100 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 DIHYDROCHLORIDECamber Pharmaceuticals, Inc.3f0d6820-ff59-40c0-882f-aeea2dd1d1ad2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1111018
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 1111018
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEMicro Labs Limited907e24c4-3337-4aee-b789-276e37a85cd82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 1111018
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1111018
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inc1590afa1-baa4-70e5-5a3b-468401c710442024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1111018
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1111018
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCb3999f74-920d-4444-afa7-f4211e4eb4312024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1111018
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPar Health USA, LLC6b2172e4-42fc-42fe-b1ad-9d6a974d43432020-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1111018

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 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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
6b2172e4-42fc-42fe-b1ad-9d6a974d4343sapropterin dihydrochloride 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 MG Powder for Oral Solution [SCD]214These highlights do not include all the information needed to use S APROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for S APROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION . SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 200720200709
1590afa1-baa4-70e5-5a3b-468401c71044sapropterin dihydrochloride 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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 TM (sapropterin dihydrochloride) powder for oral solution. Initial U.S. Approval: 200720241021
3f0d6820-ff59-40c0-882f-aeea2dd1d1adsapropterin dihydrochloride 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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 100 MG Powder for Oral Solution [PSN] · sapropterin dihydrochloride 100 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