FDA.reportPublic FDA data

CONCERTA 18 MG 24HR Extended Release Oral Tablet

RxCUI
1091157
RxNorm name
CONCERTA 18 MG 24HR Extended Release Oral Tablet
Display name
CONCERTA 18 MG 24HR Extended Release Oral Tablet
Full name
CONCERTA 18 MG 24HR Extended Release Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

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
CONCERTAMETHYLPHENIDATE HYDROCHLORIDEJanssen Pharmaceuticals, Inc.1a88218c-5b18-4220-8f56-526de1a276cd2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091157

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1a88218c-5b18-4220-8f56-526de1a276cdCONCERTA 18 MG 24HR Extended Release Oral TabletPSN30These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 200020260420
1a88218c-5b18-4220-8f56-526de1a276cd24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Concerta]SBD30These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 200020260420
1a88218c-5b18-4220-8f56-526de1a276cd24 HR Concerta 18 MG Extended Release Oral TabletSY30These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 200020260420
1a88218c-5b18-4220-8f56-526de1a276cdConcerta 18 MG 24 HR Extended Release Oral TabletSY30These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 200020260420
f63155b9-ea71-4a30-be32-37173f87bcbf24 HR Concerta 18 MG Extended Release Oral TabletSY1These highlights do not include all the information needed to use CONCERTA ® safely and effectively. See full prescribing information for CONCERTA ® . CONCERTA ® (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 200020101101
f63155b9-ea71-4a30-be32-37173f87bcbfConcerta 18 MG 24 HR Extended Release Oral TabletSY1These highlights do not include all the information needed to use CONCERTA ® safely and effectively. See full prescribing information for CONCERTA ® . CONCERTA ® (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 200020101101
f63155b9-ea71-4a30-be32-37173f87bcbfCONCERTA 18 MG 24HR Extended Release Oral TabletPSN1These highlights do not include all the information needed to use CONCERTA ® safely and effectively. See full prescribing information for CONCERTA ® . CONCERTA ® (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 200020101101
f63155b9-ea71-4a30-be32-37173f87bcbf24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Concerta]SBD1These highlights do not include all the information needed to use CONCERTA ® safely and effectively. See full prescribing information for CONCERTA ® . CONCERTA ® (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 200020101101