FDA.reportPublic FDA data

dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule

RxCUI
1101932
RxNorm name
dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule
Display name
dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule
Full name
dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

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 HYDROCHLORIDETeva Pharmaceuticals USA, Inc.dd659d39-41f5-4612-8f17-bad602b4784d2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.abe6862b-3cf3-4aad-98ea-05a5fb54ebec2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCbe7019d7-eb3e-48eb-b6ba-0ffefae6dcd02025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.edad7c67-a872-41ad-a8bd-169278693cc22025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc9cf76f62-48aa-4065-94fd-6fc910391ab52025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporation1a1da905-42a0-4748-9c39-67eca45deccc2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb7410d65-9c7f-4ffd-b957-969e2725f38f2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack06bcef7a-b321-4dd8-9bf6-5d8f8940f04a2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEPar Health USA, LLCe304388e-86a6-4335-abae-0ce79c7c99c62024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.77659abe-74be-4092-90fe-cc475726d4ec2021-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1101932

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
06bcef7a-b321-4dd8-9bf6-5d8f8940f04adexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]3104These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 200520240808
b7410d65-9c7f-4ffd-b957-969e2725f38fdexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]3102These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 200520240812
1a1da905-42a0-4748-9c39-67eca45decccdexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]336These 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
dd659d39-41f5-4612-8f17-bad602b4784ddexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]323These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 200520250430
be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]322These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 200520251009
e304388e-86a6-4335-abae-0ce79c7c99c6dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]313These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 200520240131
edad7c67-a872-41ad-a8bd-169278693cc2dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]310These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 200120250925
abe6862b-3cf3-4aad-98ea-05a5fb54ebecdexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]39Dexmethylphenidate hydrochloride extended-release capsules These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 200520251015
9cf76f62-48aa-4065-94fd-6fc910391ab5dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]35These 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
77659abe-74be-4092-90fe-cc475726d4ecdexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [SCD] · dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule [SY]31These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 200520211217