FDA.reportPublic FDA data

Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet

RxCUI
1606490
RxNorm name
Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet
Display name
Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet
Full name
Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAPHRISASENAPINE MALEATEAllergan, Inc.5429f134-839f-4ffc-9944-55f51238def82025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1606490

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
5429f134-839f-4ffc-9944-55f51238def8Saphris 2.5 MG Sublingual Tablet [PSN] · asenapine 2.5 MG Sublingual Tablet [Saphris] [SBD] · Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet [SY] · Saphris 2.5 MG Sublingual Tablet [SY]422These highlights do not include all the information needed to use SAPHRIS (asenapine) sublingual tablets safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 200920250131