FDA.reportPublic FDA data

methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet

RxCUI
1091145
RxNorm name
methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet
Display name
methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet
Full name
methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.45d33807-88b2-4b42-9c86-e5b05d7adec12026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091145
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCed004cf0-eb23-43d2-96dc-20c4ad63824f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091145
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEKVK-Tech, Inc.be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091145

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
be8580bc-0eb2-4eb6-a4cc-4ebbeb33424dmethylphenidate HCl 10 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet [SCD] · methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet [SY]314These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 195520251007
45d33807-88b2-4b42-9c86-e5b05d7adec1methylphenidate HCl 10 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet [SCD] · methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet [SY]310Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 195520260317
98be5c84-b348-6b8e-e053-2995a90ae4ccmethylphenidate HCl 10 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet [SCD] · methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet [SY]37Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 195520260423
ed004cf0-eb23-43d2-96dc-20c4ad63824fmethylphenidate HCl 10 MG 8HR Extended Release Oral Tablet [PSN] · 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet [SCD] · methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet [SY]33These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 195520251008