FDA.reportPublic FDA data

24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]

RxCUI
899463
RxNorm name
24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]
Display name
24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]
Full name
24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]
Term type
SBD
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc9cf76f62-48aa-4065-94fd-6fc910391ab52025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899463
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporation1a1da905-42a0-4748-9c39-67eca45deccc2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899463

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
1a1da905-42a0-4748-9c39-67eca45decccFocalin XR 15 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin] [SBD] · 24 HR Focalin 15 MG Extended Release Oral Capsule [SY] · Focalin XR 15 MG 24 HR Extended Release Oral Capsule [SY]436These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 200520250923
9cf76f62-48aa-4065-94fd-6fc910391ab5Focalin XR 15 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin] [SBD] · 24 HR Focalin 15 MG Extended Release Oral Capsule [SY] · Focalin XR 15 MG 24 HR Extended Release Oral Capsule [SY]45These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 200520250923
00f1d83e-93cc-4bbe-9c3b-c488062271abFocalin XR 15 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin] [SBD] · 24 HR Focalin 15 MG Extended Release Oral Capsule [SY] · Focalin XR 15 MG 24 HR Extended Release Oral Capsule [SY]42These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 200520101111
bdb43b40-d34d-47f0-b522-a0ad2d2b1185Focalin XR 15 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin] [SBD] · 24 HR Focalin 15 MG Extended Release Oral Capsule [SY] · Focalin XR 15 MG 24 HR Extended Release Oral Capsule [SY]41These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 200520110613