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Active ingredient

Methylphenidate

246 finished FDA listings contain Methylphenidate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE
Dosage forms
Capsule, Capsule, Extended Release, Patch, Solution, Suspension, Extended Release, Tablet, Tablet, Chewable, Tablet, Chewable, Extended Release, Tablet, Extended Release, Tablet, Film Coated, Extended Release, Tablet, Orally Disintegrating
Routes
Oral, Transdermal
Manufacturers / labelers
47
Strengths listed
1.1 mg/h · 1.6 mg/h · 10 mg/1 · 10 mg/5ml · 10 mg/9h · 100 mg/1 · 15 mg/1 · 15 mg/9h · 17.3 mg/1 · 18 mg/1 · 2.2 mg/h · 2.5 mg/1 · 20 mg/1 · 20 mg/9h · 25.9 mg/1 · 27 mg/1 · 27.5 mg/mg · 3.3 mg/h · 30 mg/1 · 30 mg/9h · 300 mg/60ml · 36 mg/1 · 40 mg/1 · 41.3 mg/mg · 45 mg/1 · 5 mg/1 · 5 mg/5ml · 50 mg/1 · 54 mg/1 · 55 mg/mg · 60 mg/1 · 600 mg/120ml · 63 mg/1 · 72 mg/1 · 750 mg/150ml · 8.6 mg/1 · 80 mg/1 · 82.5 mg/mg · 900 mg/180ml
Brand names in FDA listings
Concerta, Cotempla Xr-Odt, Daytrana, Jornay Pm Extended-Release, Metadate Cd, Methylin, Methylphenidate, Methylphenidate Hydrochloride (La), Methylphenidate Hydrochloride Cd, Methylphenidate Hydrochloride Extended-Release, Methylphenidate Transdermal System, Quillichew Er, Quillivant Xr, Relexxii, Ritalin, Ritalin La

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6901

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 010187SANDOZ1955-12-053
ANDA 040300SPECGX LLC1998-11-275
NDA 021121JANSSEN PHARMS2000-08-014
NDA 021259LANNETT2001-04-0318
NDA 021284SANDOZ2002-06-0512
NDA 021514NOVEN PHARMS INC2006-04-068
ANDA 091601TRIS PHARMA INC2010-07-234
ANDA 078458DR REDDYS LABS SA2011-12-014
ANDA 090710SUN PHARM INDS INC2012-03-155
NDA 202100NEXTWAVE2012-09-274
ANDA 202608SPECGX LLC2012-12-283
ANDA 091695LANNETT CO INC2013-07-096
ANDA 091159MOUNTAIN2014-03-126
ANDA 204115NOVEL LABS INC2015-02-253
NDA 205831RHODES PHARMS2015-04-177
ANDA 207416ASCENT PHARMS INC2015-09-227
ANDA 203583SPECGX LLC2015-09-296
ANDA 207884NOVEL LABS INC2015-11-133
NDA 207960NEXTWAVE PHARMS2015-12-043
ANDA 205105IMPAX LABS INC2016-07-286
ANDA 205756RISING2016-11-073
ANDA 206932ABHAI LLC2017-05-113
NDA 205489NEOS THERAPS INC2017-06-196
ANDA 205327OSMOTICA PHARM US2017-07-289
ANDA 210354ASCENT PHARMS INC2017-12-297
ANDA 076772ACTAVIS LABS FL2018-03-223
NDA 209311IRONSHORE PHARMS2018-08-085
ANDA 210139ADAPTIS2018-10-036
ANDA 209276AUROLIFE PHARMA LLC2018-10-253
ANDA 210992GRANULES2018-11-214
ANDA 208861ACTAVIS ELIZABETH2018-12-137
ANDA 208737CEDIPROF INC2019-02-017
ANDA 211918ANDOR PHARMS2019-04-244
ANDA 211796GRANULES2019-05-235
ANDA 211009ASCENT PHARMS INC2019-09-0312
ANDA 211779ALKEM LABS LTD2019-10-043
ANDA 212697PRINSTON INC2020-07-233
ANDA 213936ACCORD HLTHCARE2020-10-283
ANDA 206497MYLAN TECH VIATRIS2022-03-144
NDA 216117OSMOTICA PHARM US2022-06-239

Showing 40 of 53 applications.

Official labeling on DailyMed

Showing the 12 most recent of 83 labels.

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