FDA.reportPublic FDA data

asenapine (as asenapine maleate) 10 MG Sublingual Tablet

RxCUI
859975
RxNorm name
asenapine (as asenapine maleate) 10 MG Sublingual Tablet
Display name
asenapine (as asenapine maleate) 10 MG Sublingual Tablet
Full name
asenapine (as asenapine maleate) 10 MG 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 · 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: 859975
AsenapineASENAPINEAlembic Pharmaceuticals Inc.16e1cc9f-7699-49ea-b179-acb65e1623042025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859975
SAPHRISASENAPINE MALEATEAllergan, Inc.5429f134-839f-4ffc-9944-55f51238def82025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859975
AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859975
AsenapineASENAPINEAlembic Pharmaceuticals Limitedcf587c48-9cd2-4dc5-b0e9-21783c5633a62023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859975
AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITED4c7a1b17-e73e-4417-a172-bfb03569d7ff2021-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859975

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5429f134-839f-4ffc-9944-55f51238def8asenapine 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 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
03c696e9-0e6b-4e5c-be0a-41416f8019beasenapine 10 MG Sublingual Tablet [PSN] · asenapine 10 MG Sublingual Tablet [SCD] · asenapine (as asenapine maleate) 10 MG Sublingual Tablet [SY]31These highlights do not include all the information needed to use SAPHRIS ® (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS (asenapine) sublingual tablets Initial U.S. Approval: 200920110216