FDA — authorised 4 April 1979
- Application: ANDA086428
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Concerta in United States
FDA authorised Concerta on 4 April 1979 · 8,388 US adverse-event reports
Marketing authorisations
FDA — authorised 4 April 1979
- Application: ANDA086429
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 1988
- Application: ANDA089601
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METADATE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 August 1997
- Application: ANDA040220
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1998
- Application: ANDA040300
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 1999
- Application: ANDA040306
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METADATE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 August 2000
- Application: NDA021121
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
FDA — authorised 9 May 2001
- Application: ANDA076032
- Marketing authorisation holder: ABLE
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 December 2001
- Application: ANDA075450
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 February 2002
- Application: ANDA040321
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2010
- Application: ANDA091601
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 July 2012
- Application: ANDA078873
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 July 2012
- Application: ANDA077707
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 December 2012
- Application: ANDA202608
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 March 2014
- Application: ANDA091159
- Marketing authorisation holder: MOUNTAIN
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 2014
- Application: ANDA202892
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2015
- Application: ANDA204115
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 9 June 2015
- Application: ANDA207488
- Marketing authorisation holder: ABHAI LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 September 2015
- Application: ANDA207416
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 2015
- Application: ANDA203583
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 November 2015
- Application: ANDA207884
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2015
- Application: NDA207960
- Marketing authorisation holder: NEXTWAVE PHARMS
- Local brand name: QUILLICHEW ER
- Indication: TABLET, EXTENDED RELEASE, CHEWABLE — ORAL
- Status: approved
FDA — authorised 29 February 2016
- Application: ANDA204772
- Marketing authorisation holder: ALVOGEN
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 September 2016
- Application: ANDA206840
- Marketing authorisation holder: ALVOGEN
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 2016
- Application: ANDA207485
- Marketing authorisation holder: ABHAI LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 March 2017
- Application: ANDA207587
- Marketing authorisation holder: MPP PHARMA
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 2017
- Application: ANDA208607
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 December 2017
- Application: ANDA210354
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 1 February 2018
- Application: ANDA207515
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 February 2018
- Application: ANDA200886
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 March 2018
- Application: ANDA209753
- Marketing authorisation holder: BIONPHARMA
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2018
- Application: ANDA076772
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 May 2018
- Application: ANDA206049
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: FOR SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA210139
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 October 2018
- Application: ANDA209276
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2018
- Application: ANDA210992
- Marketing authorisation holder: GRANULES
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA210818
- Marketing authorisation holder: ALVOGEN
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 February 2019
- Application: ANDA208737
- Marketing authorisation holder: CEDIPROF INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2019
- Application: ANDA211796
- Marketing authorisation holder: GRANULES
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 September 2019
- Application: ANDA211009
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 October 2019
- Application: ANDA211779
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2020
- Application: ANDA210764
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 4 June 2020
- Application: ANDA213567
- Marketing authorisation holder: QUAGEN
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 July 2020
- Application: ANDA212697
- Marketing authorisation holder: PRINSTON INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2020
- Application: ANDA213473
- Marketing authorisation holder: GRANULES
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 August 2020
- Application: ANDA205135
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA207414
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 January 2021
- Application: ANDA207417
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 June 2022
- Application: NDA216117
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: RELEXXII
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 May 2023
- Application: ANDA214447
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: METHYLPHENIDATE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 8,388
Most-reported reactions
- Drug Ineffective — 1,771 reports (21.11%)
- Headache — 908 reports (10.82%)
- Off Label Use — 890 reports (10.61%)
- Nausea — 788 reports (9.39%)
- Anxiety — 775 reports (9.24%)
- Fatigue — 754 reports (8.99%)
- Insomnia — 670 reports (7.99%)
- Depression — 652 reports (7.77%)
- Suicidal Ideation — 613 reports (7.31%)
- Aggression — 567 reports (6.76%)
Concerta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Concerta approved in United States?
Yes. FDA authorised it on 4 April 1979; FDA authorised it on 4 April 1979; FDA authorised it on 1 June 1988.
Who is the marketing authorisation holder for Concerta in United States?
LANNETT CO INC holds the US marketing authorisation.