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Active ingredient

Dexmethylphenidate

110 finished FDA listings contain Dexmethylphenidate as their only active ingredient; 3 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DEXMETHYLPHENIDATE, DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage forms
Capsule, Extended Release, Tablet
Routes
Oral
Manufacturers / labelers
15
Strengths listed
10 mg/1 · 15 mg/1 · 2.5 mg/1 · 20 mg/1 · 25 mg/1 · 30 mg/1 · 35 mg/1 · 40 mg/1 · 5 mg/1
Brand names in FDA listings
Dexmethylphenidate Hydrochloride Extended-Release, Focalin, Focalin Xr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 352372

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021278SANDOZ2001-11-133
NDA 021802SANDOZ2005-05-2620
ANDA 078992PLATINUM2013-11-186
ANDA 202731TEVA PHARMS USA2013-11-194
ANDA 078908TEVA PHARMS USA2013-11-194
ANDA 079108IMPAX LABS INC2013-11-215
ANDA 201231SUN PHARM INDUSTRIES2015-09-243
ANDA 204534NOVEL LABS INC2015-12-043
ANDA 206931ABHAI LLC2015-12-043
ANDA 207901TRIS PHARMA INC2016-08-269
ANDA 202842PH HEALTH2016-11-3017
ANDA 203614IMPAX LABS INC2017-07-052
ANDA 209211CEDIPROF INC2018-09-194
ANDA 210279ADARE PHARMS INC2018-10-098
ANDA 212631ALKEM LABS LTD2019-07-193
ANDA 213813GRANULES2020-09-098
ANDA 215523ASCENT PHARMS INC2021-12-088

Official labeling on DailyMed

Showing the 12 most recent of 40 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.