FDA.reportPublic FDA data

asenapine 5 MG Sublingual Tablet

RxCUI
859981
RxNorm name
asenapine 5 MG Sublingual Tablet
Display name
asenapine 5 MG Sublingual Tablet
Full name
asenapine 5 MG Sublingual Tablet
Term type
SCD
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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASENAPINEASENAPINESigmapharm Laboratories, LLC3512687b-d1c7-45c4-8822-3a2ad53575a52025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
AsenapineASENAPINEAlembic Pharmaceuticals Inc.16e1cc9f-7699-49ea-b179-acb65e1623042025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
SAPHRISASENAPINE MALEATEAllergan, Inc.5429f134-839f-4ffc-9944-55f51238def82025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
AsenapineASENAPINEAlembic Pharmaceuticals Limitedcf587c48-9cd2-4dc5-b0e9-21783c5633a62023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITED4c7a1b17-e73e-4417-a172-bfb03569d7ff2021-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5429f134-839f-4ffc-9944-55f51238def8asenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]322These 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
16e1cc9f-7699-49ea-b179-acb65e162304asenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]316These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets Initial U.S. Approval: 200920250225
3512687b-d1c7-45c4-8822-3a2ad53575a5asenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]311These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets, for oral use Initial U.S. Approval: 200920251125
4c7a1b17-e73e-4417-a172-bfb03569d7ffasenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]37These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets Initial U.S. Approval: 200920210826
f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7easenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]35These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets Initial U.S. Approval: 200920240213
cf587c48-9cd2-4dc5-b0e9-21783c5633a6asenapine 5 MG Sublingual Tablet [PSN] · asenapine 5 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 5 MG Sublingual Tablet [SY]33These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets Initial U.S. Approval: 200920230120