FDA.reportPublic FDA data

dexmethylphenidate hydrochloride 5 MG Oral Tablet

RxCUI
899518
RxNorm name
dexmethylphenidate hydrochloride 5 MG Oral Tablet
Display name
dexmethylphenidate hydrochloride 5 MG Oral Tablet
Full name
dexmethylphenidate hydrochloride 5 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack90308fd0-d174-4979-aa22-16290d6cc5bb2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDENivagen Pharmaceuticals, Inc.638f614c-bf91-4bf6-876f-bf25fa273bc42026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC0c717ae4-ec27-47db-ac1b-e504dbb379be2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDECranbury Pharmaceuticals, LLC1f2aa66a-51dc-459c-a765-5364bccd310f2024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC830df993-db01-40df-beef-90af6b86f5612024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackf930af78-760b-42c7-af30-ffcc64c4d35d2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
FocalinDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc2016f5c2-95d2-4655-af65-c588c2bf5e6d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack17950616-ab96-4d7e-be48-f36cae547de02024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.a61932ef-c2b6-4363-a21d-1f0358f317b62024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.987b4983-1edc-40f1-adc9-7247470809692024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 13 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f930af78-760b-42c7-af30-ffcc64c4d35ddexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 5 MG Oral Tablet [SCD]2104These 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: 200120240605
90308fd0-d174-4979-aa22-16290d6cc5bbdexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 5 MG Oral Tablet [SCD]2101These 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: 200120260317
17950616-ab96-4d7e-be48-f36cae547de0dexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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
76b7fd4a-c523-4b35-e053-2a91aa0a4a89dexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 5 MG Oral Tablet [SCD]213HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 200120241212
987b4983-1edc-40f1-adc9-724747080969dexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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
638f614c-bf91-4bf6-876f-bf25fa273bc4dexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 5 MG Oral Tablet [SCD]22These 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: 200120260101
2016f5c2-95d2-4655-af65-c588c2bf5e6ddexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 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
8b379f0f-8622-49c8-9cdc-3bb4cf2d92fddexmethylphenidate HCl 5 MG Oral Tablet [PSN] · dexmethylphenidate hydrochloride 5 MG Oral Tablet [SCD]21These 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: 200120200401