FDA.reportPublic FDA data

dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule

RxCUI
2562194
RxNorm name
dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule
Display name
dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule
Full name
dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
AZSTARYSSERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATECommave Sub, LLC00b5e716-5564-4bbd-acaf-df2bc45a56632026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2562194

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
00b5e716-5564-4bbd-acaf-df2bc45a5663dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule [PSN] · dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule [SCD] · dexmethylphenidate 10.4 MG (as dexmethylphenidate hydrochloride 12 MG) / serdexmethylphenidate 52.3 MG (as serdexmethylphenidate chloride 56 MG) Oral Capsule [SY]39These highlights do not include all the information needed to use AZSTARYS safely and effectively. See full prescribing information for AZSTARYS. AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) capsules, for oral use, CII Initial U.S. Approval: 202120260511