FDA.reportPublic FDA data

apremilast 10 MG Oral Tablet [Otezla]

RxCUI
1492738
RxNorm name
apremilast 10 MG Oral Tablet [Otezla]
Display name
apremilast 10 MG Oral Tablet [Otezla]
Full name
apremilast 10 MG Oral Tablet [Otezla]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

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
OtezlaAPREMILASTAmgen, Incf6b1f516-4972-4d82-bced-113e47b41cc52025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 1492738

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
f6b1f516-4972-4d82-bced-113e47b41cc5Otezla 10 MG Oral Tablet [PSN] · apremilast 10 MG Oral Tablet [Otezla] [SBD] · Otezla 10 MG Oral Tablet [SY]334These highlights do not include all the information needed to use OTEZLA/OTEZLA XR safely and effectively. See full prescribing information for OTEZLA/OTEZLA XR. OTEZLA ® (apremilast) tablets, for oral use OTEZLA XR™ (apremilast) extended-release tablets, for oral use Initial U.S. Approval: 201420251223