FDA.reportPublic FDA data

JORNAY PM 40 MG 24HR Extended Release Oral Capsule

RxCUI
2168869
RxNorm name
JORNAY PM 40 MG 24HR Extended Release Oral Capsule
Display name
JORNAY PM 40 MG 24HR Extended Release Oral Capsule
Full name
JORNAY PM 40 MG 24HR Extended Release Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

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
JORNAY PM Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDEIronshore Pharmaceuticals Inc.d95dede0-b1ff-4489-8f91-3bbe122852bf2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2168869

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
d95dede0-b1ff-4489-8f91-3bbe122852bfJORNAY PM 40 MG 24HR Extended Release Oral Capsule [PSN] · Evening Dosing 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Jornay] [SBD] · Evening Dosing 24 HR Jornay 40 MG Extended Release Oral Capsule [SY] · Jornay PM 40 MG 24HR Extended Release Oral Capsule [SY]416These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 195520251003