FDA.reportPublic FDA data

Cotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral Tablet

RxCUI
1926855
RxNorm name
Cotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral Tablet
Display name
Cotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral Tablet
Full name
Cotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral Tablet
Term type
PSN
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#

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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
Cotempla XR-ODTMETHYLPHENIDATENeos Therapeutics Brands, LLC33f70f58-c871-42c8-8adb-345caeafefcd2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1926855

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
33f70f58-c871-42c8-8adb-345caeafefcdCotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral TabletPSN15These 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
33f70f58-c871-42c8-8adb-345caeafefcdmethylphenidate 8.6 MG Disintegrating Oral Tablet [Cotempla]SBD15These 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
33f70f58-c871-42c8-8adb-345caeafefcdCotempla 8.6 MG Disintegrating Oral TabletSY15These 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