FDA.reportPublic FDA data

dexmethylphenidate HCl 2.5 MG Oral Tablet

RxCUI
899557
RxNorm name
dexmethylphenidate HCl 2.5 MG Oral Tablet
Display name
dexmethylphenidate HCl 2.5 MG Oral Tablet
Full name
dexmethylphenidate HCl 2.5 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC0c717ae4-ec27-47db-ac1b-e504dbb379be2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDECranbury Pharmaceuticals, LLC1f2aa66a-51dc-459c-a765-5364bccd310f2024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC830df993-db01-40df-beef-90af6b86f5612024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
FocalinDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc2016f5c2-95d2-4655-af65-c588c2bf5e6d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackea04c0e3-0be3-4607-bd59-29f611e6681b2024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.a61932ef-c2b6-4363-a21d-1f0358f317b62024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.987b4983-1edc-40f1-adc9-7247470809692024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
194bb3a5-5f6c-49e3-85ab-ac557b3f8bbddexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]2103These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240110
ea04c0e3-0be3-4607-bd59-29f611e6681bdexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]2100These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240201
7c552f11-e24a-4d9b-bb8d-be10c928eca8dexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]228These highlights do not include all the information needed to use FOCALIN safely and effectively. See full prescribing information for FOCALIN. FOCALIN ® (dexmethylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 200120231013
1f2aa66a-51dc-459c-a765-5364bccd310fdexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]223These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240731
0c717ae4-ec27-47db-ac1b-e504dbb379bedexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]214These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120251124
987b4983-1edc-40f1-adc9-724747080969dexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]213These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240102
830df993-db01-40df-beef-90af6b86f561dexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240716
a61932ef-c2b6-4363-a21d-1f0358f317b6dexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS s afely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS . DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120240130
2016f5c2-95d2-4655-af65-c588c2bf5e6ddexmethylphenidate HCl 2.5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use FOCALIN safely and effectively. See full prescribing information for FOCALIN. FOCALIN ® (dexmethylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 200120240530