FDA.reportPublic FDA data

dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]

RxCUI
996101
RxNorm name
dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]
Display name
dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]
Full name
dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JalynDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEWaylis Therapeuticsaab9a2d4-5328-40f3-986f-e7753a928bc02026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 996101

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
aab9a2d4-5328-40f3-986f-e7753a928bc0Jalyn 0.5 MG / 0.4 MG Oral Capsule [PSN] · dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn] [SBD] · Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral Capsule [SY]34These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) capsules Initial U.S. Approval: 201020260309
f96c6acd-4d02-4ece-bd54-2d5a35aab7f5Jalyn 0.5 MG / 0.4 MG Oral Capsule [PSN] · dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn] [SBD] · Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral Capsule [SY]31These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN. JALYN (dutasteride and tamsulosin hydrochloride) Capsules Initial U.S. Approval: 201020120516