FDA.reportPublic FDA data

methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla]

RxCUI
1926851
RxNorm name
methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla]
Display name
methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla]
Full name
methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

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
Cotempla XR-ODTMETHYLPHENIDATENeos Therapeutics Brands, LLC33f70f58-c871-42c8-8adb-345caeafefcd2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1926851

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
33f70f58-c871-42c8-8adb-345caeafefcdCotempla XR-ODT 25.9 MG Extended Release Disintegrating Oral Tablet [PSN] · methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla] [SBD] · Cotempla 25.9 MG Disintegrating Oral Tablet [SY]315These highlights do not include all the information needed to use COTEMPLA XR-ODT safely and effectively. See full prescribing information for COTEMPLA XR-ODT. COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII Initial U.S. Approval: 195520250924