FDA.reportPublic FDA data

Hetlioz 20 MG Oral Capsule

RxCUI
1491624
RxNorm name
Hetlioz 20 MG Oral Capsule
Display name
Hetlioz 20 MG Oral Capsule
Full name
Hetlioz 20 MG Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HetliozTASIMELTEONVanda Pharmaceuticals Inc.ca4a9b63-708e-49e9-8f9b-010625443b902026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 1491624

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ca4a9b63-708e-49e9-8f9b-010625443b90Hetlioz 20 MG Oral Capsule [PSN] · tasimelteon 20 MG Oral Capsule [Hetlioz] [SBD] · Hetlioz 20 MG Oral Capsule [SY]313These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ™ (tasimelteon) oral suspension Initial U.S. Approval: 201420221221