Methylphenidate Extended Release Oral Tablet

Brand(s)
Concerta, Metadate, Ritalin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2015-09-25)
Oldest Current Product
1982-03-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\METHYLPHENIDATE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
ORAL\TABLET\METHYLPHENIDATE HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
ORAL\TABLET\METHYLPHENIDATE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\METHYLPHENIDATE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METHYLPHENIDATE
ORAL\TABLET\METHYLPHENIDATE

product(s) by strength(s)

8 hr methylphenidate hydrochloride 10 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061445ANDAMallinckrodt, Inc.2011-03-18METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA075629981a2ad8-33f7-4678-9162-9df9685bd4a6
2107020075ANDAKvk-Tech, Inc.2015-06-09METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA207488be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290579ANDAGolden State Medical Supply, Inc.2010-05-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE004061445ANDA075629cc0b862e-1c28-4adb-b9b7-e83ef5152cb6

24 hr methylphenidate hydrochloride 18 mg extended release oral tablet

original product(s)(s)

#idbrandlabeleractive ingredient(s)routedose formspl
1504580585ConcertaJanssen Pharmaceuticals, Inc.METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE1a88218c-5b18-4220-8f56-526de1a276cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422910601ANDAAvkare, Inc.2014-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA09169501695073-5ed5-dc7e-71db-7ad1d87bce22
2621750310ANDAKremers Urban Pharmaceuticals Inc.2013-07-10METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA0916953d1f5aff-5d39-496c-b5ed-7f3c70ec641c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684489ConcertaNDAPhysicians Total Care, Inc.2003-03-21METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE504580585NDA021121f63155b9-ea71-4a30-be32-37173f87bcbf

8 hr methylphenidate hydrochloride 20 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780442RitalinNDANovartis Pharmaceuticals Corporation1982-03-312015-02-28METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA018029c0bf0835-6a2f-4067-a158-8b86c4b0668a

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061473ANDAMallinckrodt, Inc.2011-03-18METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA075629981a2ad8-33f7-4678-9162-9df9685bd4a6
2007815754NDA AUTHORIZED GENERICSandoz Inc1982-03-31METHYLPHENIDATE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA0180294e50d72b-9437-4a23-b2f3-f7a43ad3934e
3107020076ANDAKvk-Tech, Inc.2015-06-09METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA207488be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d
4530140594MetadateANDACelltech Pharmaceuticals, Inc.1988-06-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA089601739bbd64-d9e1-4771-967b-a2cd08f4eaf5
5655800594MetadateANDAUpstate Pharma, Llc2014-11-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA089601084f8412-dab8-4418-91dd-06655cd00206

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683454ANDAPhysicians Total Care, Inc.1994-12-16METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE007818843ANDA086428f931d3af-c32a-4406-8799-9b097f41594b
2604290580ANDAGolden State Medical Supply, Inc.2010-05-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE004061473ANDA075629cc0b862e-1c28-4adb-b9b7-e83ef5152cb6

24 hr methylphenidate hydrochloride 27 mg extended release oral tablet

original product(s)(s)

#idbrandlabeleractive ingredient(s)routedose formspl
1504580588ConcertaJanssen Pharmaceuticals, Inc.METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE1a88218c-5b18-4220-8f56-526de1a276cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004060127ANDAMallinckrodt, Inc.2012-06-30METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA202608b1b0f2ff-d9df-42ab-b471-226ecf97e075
2005912716NDA AUTHORIZED GENERICWatson Laboratories, Inc.2011-04-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA021121038ae416-4bd5-411b-bd28-d4f0af5c2ab7
3422910602ANDAAvkare, Inc.2014-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA09169501695073-5ed5-dc7e-71db-7ad1d87bce22
4621750311ANDAKremers Urban Pharmaceuticals Inc.2013-07-10METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA0916953d1f5aff-5d39-496c-b5ed-7f3c70ec641c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684957ConcertaNDAPhysicians Total Care, Inc.2003-11-13METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE504580588NDA021121f63155b9-ea71-4a30-be32-37173f87bcbf
2548686262NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2011-06-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET005912716NDA0211212bfb390f-ba99-4d21-8a9e-50fa8ec217c0
3680840816NDA AUTHORIZED GENERICAmerican Health Packaging2014-09-04METHYLPHENIDATE HYDROCHLORIDEORALTABLET005912716NDA02112115b53374-8d97-496b-9561-1f4f3568926b

24 hr methylphenidate hydrochloride 36 mg extended release oral tablet

original product(s)(s)

#idbrandlabeleractive ingredient(s)routedose formspl
1504580586ConcertaJanssen Pharmaceuticals, Inc.METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE1a88218c-5b18-4220-8f56-526de1a276cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004060136ANDAMallinckrodt, Inc.2012-06-30METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA202608b1b0f2ff-d9df-42ab-b471-226ecf97e075
2005912717NDA AUTHORIZED GENERICWatson Laboratories, Inc.2011-04-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA021121038ae416-4bd5-411b-bd28-d4f0af5c2ab7
3422910603ANDAAvkare, Inc.2014-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA09169501695073-5ed5-dc7e-71db-7ad1d87bce22
4621750312ANDAKremers Urban Pharmaceuticals Inc.2013-09-23METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA0916953d1f5aff-5d39-496c-b5ed-7f3c70ec641c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684759ConcertaNDAPhysicians Total Care, Inc.2003-03-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE504580586NDA021121f63155b9-ea71-4a30-be32-37173f87bcbf
2680840829NDA AUTHORIZED GENERICAmerican Health Packaging2014-09-04METHYLPHENIDATE HYDROCHLORIDEORALTABLET005912717NDA02112115b53374-8d97-496b-9561-1f4f3568926b

24 hr methylphenidate hydrochloride 54 mg extended release oral tablet

original product(s)(s)

#idbrandlabeleractive ingredient(s)routedose formspl
1504580587ConcertaJanssen Pharmaceuticals, Inc.METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE1a88218c-5b18-4220-8f56-526de1a276cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004060154ANDAMallinckrodt, Inc.2012-06-30METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA202608b1b0f2ff-d9df-42ab-b471-226ecf97e075
2005912718NDA AUTHORIZED GENERICWatson Laboratories, Inc.2011-04-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA021121038ae416-4bd5-411b-bd28-d4f0af5c2ab7
3422910604ANDAAvkare, Inc.2014-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA09169501695073-5ed5-dc7e-71db-7ad1d87bce22
4621750313ANDAKremers Urban Pharmaceuticals Inc.2013-09-23METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA0916953d1f5aff-5d39-496c-b5ed-7f3c70ec641c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684789ConcertaNDAPhysicians Total Care, Inc.2003-05-08METHYLPHENIDATE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE504580587NDA021121f63155b9-ea71-4a30-be32-37173f87bcbf
2680840833NDA AUTHORIZED GENERICAmerican Health Packaging2014-09-04METHYLPHENIDATE HYDROCHLORIDEORALTABLET005912718NDA02112115b53374-8d97-496b-9561-1f4f3568926b

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA040220METHYLPHENIDATE HYDROCHLORIDEACTAVIS LABORATORIES FL INC1997-08-29ANDA040220_001, ANDA040220_002, ANDA040220_003Methylphenidate Oral Tablet
2ANDA040300METHYLPHENIDATE HYDROCHLORIDEMALLINCKRODT INC1998-11-27ANDA040300_001, ANDA040300_002, ANDA040300_003Methylphenidate Oral Tablet
3ANDA040306METADATE ERTrueUCB INC1999-10-20ANDA040306_001
4ANDA040321METHYLPHENIDATE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2002-02-05ANDA040321_001, ANDA040321_002, ANDA040321_003Methylphenidate Oral Tablet
5ANDA040404METHYLPHENIDATE HYDROCHLORIDETrueABLE LABORATORIES INC2001-03-29ANDA040404_001, ANDA040404_002, ANDA040404_003Methylphenidate Oral Tablet
6ANDA040410METHYLPHENIDATE HYDROCHLORIDETrueWATSON LABORATORIES INC2001-02-09ANDA040410_001
7ANDA075450METHYLPHENIDATE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2001-12-21ANDA075450_001
8ANDA075629METHYLIN ERMALLINCKRODT INC2000-05-09ANDA075629_001, ANDA075629_002
9ANDA076032METHYLPHENIDATE HYDROCHLORIDETrueABLE LABORATORIES INC2001-05-09ANDA076032_001
10ANDA085799METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA085799_001Methylphenidate Oral Tablet
11ANDA086428METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA086428_001Methylphenidate Oral Tablet
12ANDA086429METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA086429_001Methylphenidate Oral Tablet
13ANDA089601METADATE ERUCB INC1988-06-01ANDA089601_001
14ANDA090710METHYLPHENIDATE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2012-03-15ANDA090710_001, ANDA090710_002, ANDA090710_003Methylphenidate Oral Tablet
15ANDA091159METHYLPHENIDATE HYDROCHLORIDECOREPHARMA LLC2014-03-12ANDA091159_001, ANDA091159_002, ANDA091159_003Methylphenidate Oral Tablet
16ANDA091695METHYLPHENIDATE HYDROCHLORIDEKUDCO IRELAND LTD2013-07-09ANDA091695_001, ANDA091695_002, ANDA091695_003, ANDA091695_004
17ANDA202608METHYLPHENIDATE HYDROCHLORIDEMALLINCKRODT INC2012-12-28ANDA202608_001, ANDA202608_002, ANDA202608_003
18ANDA202892METHYLPHENIDATE HYDROCHLORIDEVINTAGE PHARMACEUTICALS2014-09-23ANDA202892_001, ANDA202892_002, ANDA202892_003Methylphenidate Oral Tablet
19ANDA207416METHYLPHENIDATE HYDROCHLORIDEASCENT PHARMACEUTICALS INC2015-09-22ANDA207416_001, ANDA207416_002, ANDA207416_003Methylphenidate Oral Tablet
20ANDA207488METHYLPHENIDATE HYDROCHLORIDEABHAI LLC2015-06-09ANDA207488_001, ANDA207488_002
21NDA010187RITALINNOVARTIS PHARMACEUTICALS CORPNDA010187_003, NDA010187_006, NDA010187_010Methylphenidate Oral Tablet
22NDA018029RITALIN-SRNOVARTIS PHARMACEUTICALS CORP1982-03-30NDA018029_001
23NDA021121CONCERTAJANSSEN PHARMACEUTICALS INC2000-08-01p8163798, SUBSTANCE
p9144549, FOR CLAIMS 1-4/ FOR CLAIMS 1-3
p9029416, METHOD OF TREATING ADHD, SUBSTANCE
p6919373, METHOD OF TREATING ADHD
p6930129, METHOD OF TREATING ADHD
p9000038, METHOD OF TREATING ADHD/ METHOD OF TREATING ADHD IN CHILDREN 6 YEARS OF AGE AND OLDER AND ADOLESCENTS
p8629179, SUBSTANCE
NDA021121_001, NDA021121_002, NDA021121_003, NDA021121_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040220_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1997-08-29METHYLPHENIDATE HYDROCHLORIDE
2ANDA040220_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1997-08-29METHYLPHENIDATE HYDROCHLORIDE
3ANDA040220_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB1997-08-29METHYLPHENIDATE HYDROCHLORIDE
4ANDA040300_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1998-11-27METHYLPHENIDATE HYDROCHLORIDE
5ANDA040300_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1998-11-27METHYLPHENIDATE HYDROCHLORIDE
6ANDA040300_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB1998-11-27METHYLPHENIDATE HYDROCHLORIDE
7ANDA040306_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalse1999-10-20METADATE ER
8ANDA040321_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
9ANDA040321_002discontinuedMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
10ANDA040321_003discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
11ANDA040404_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
12ANDA040404_002discontinuedMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
13ANDA040404_003discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
14ANDA040410_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalse2001-02-09METHYLPHENIDATE HYDROCHLORIDE
15ANDA075450_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalse2001-12-21METHYLPHENIDATE HYDROCHLORIDE
16ANDA075629_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2000-05-09METHYLIN ER
17ANDA075629_002RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalseAB2000-05-09METHYLIN ER
18ANDA076032_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalse2001-05-09METHYLPHENIDATE HYDROCHLORIDE
19ANDA085799_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
20ANDA086428_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
21ANDA086429_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
22ANDA089601_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASETrueAB1988-06-01METADATE ER
23ANDA090710_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
24ANDA090710_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
25ANDA090710_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
26ANDA091159_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
27ANDA091159_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
28ANDA091159_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
29ANDA091695_001RXMETHYLPHENIDATE HYDROCHLORIDE (18MG)ORALTABLET, EXTENDED RELEASEFalseBX2013-07-09METHYLPHENIDATE HYDROCHLORIDE
30ANDA091695_002RXMETHYLPHENIDATE HYDROCHLORIDE (27MG)ORALTABLET, EXTENDED RELEASEFalseBX2013-07-09METHYLPHENIDATE HYDROCHLORIDE
31ANDA091695_003RXMETHYLPHENIDATE HYDROCHLORIDE (36MG)ORALTABLET, EXTENDED RELEASEFalseBX2013-09-23METHYLPHENIDATE HYDROCHLORIDE
32ANDA091695_004RXMETHYLPHENIDATE HYDROCHLORIDE (54MG)ORALTABLET, EXTENDED RELEASEFalseBX2013-09-23METHYLPHENIDATE HYDROCHLORIDE
33ANDA202608_001RXMETHYLPHENIDATE HYDROCHLORIDE (27MG)ORALTABLET, EXTENDED RELEASEFalseBX2012-12-28METHYLPHENIDATE HYDROCHLORIDE
34ANDA202608_002RXMETHYLPHENIDATE HYDROCHLORIDE (36MG)ORALTABLET, EXTENDED RELEASEFalseBX2012-12-28METHYLPHENIDATE HYDROCHLORIDE
35ANDA202608_003RXMETHYLPHENIDATE HYDROCHLORIDE (54MG)ORALTABLET, EXTENDED RELEASEFalseBX2012-12-28METHYLPHENIDATE HYDROCHLORIDE
36ANDA202892_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
37ANDA202892_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
38ANDA202892_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
39ANDA207416_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
40ANDA207416_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
41ANDA207416_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
42ANDA207488_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-06-09METHYLPHENIDATE HYDROCHLORIDE
43ANDA207488_002RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-06-09METHYLPHENIDATE HYDROCHLORIDE
44NDA010187_003RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseABRITALIN
45NDA010187_006RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseABRITALIN
46NDA010187_010RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETTrueABRITALIN
47NDA018029_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLET, EXTENDED RELEASEFalseAB1982-03-30RITALIN-SR
48NDA021121_001RXMETHYLPHENIDATE HYDROCHLORIDE (18MG)ORALTABLET, EXTENDED RELEASEFalse2000-08-01CONCERTA
49NDA021121_002RXMETHYLPHENIDATE HYDROCHLORIDE (36MG)ORALTABLET, EXTENDED RELEASEFalse2000-08-01CONCERTA
50NDA021121_003RXMETHYLPHENIDATE HYDROCHLORIDE (54MG)ORALTABLET, EXTENDED RELEASETrue2000-12-08CONCERTA
51NDA021121_004RXMETHYLPHENIDATE HYDROCHLORIDE (27MG)ORALTABLET, EXTENDED RELEASEFalse2002-04-01CONCERTA

patent(s)

#idexpiration dateapplication(s)
1p6919373 (view patent)2017-07-31NDA021121
2p6930129 (view patent)2017-07-31NDA021121
3p8163798 (view patent)2017-07-31NDA021121
4p8629179 (view patent)2017-07-31NDA021121
5p9000038 (view patent)2017-07-31NDA021121
6p9029416 (view patent)2017-07-31NDA021121
7p9144549 (view patent)2017-07-31NDA021121

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101695073-5ed5-dc7e-71db-7ad1d87bce22 (view SPL)These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets.METHYLPHENIDATEhydrochloride extended-release tablets, USP for oral useCII Initial U.S. Approval: 2000prescriptionHuman PrescriptionAvkare, Inc.2015-05-115422910601, 422910602, 422910603, 422910604
2038ae416-4bd5-411b-bd28-d4f0af5c2ab7 (view SPL)These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets. Methylphenidate HCl Extended-Release Tablets CII Initial U.S. Approval: 2000prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-2510005912716, 005912717, 005912718, 005912715
3084f8412-dab8-4418-91dd-06655cd00206 (view SPL)Metadate ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) CIIprescriptionHuman PrescriptionUpstate Pharma, Llc2015-08-272655800594
415b53374-8d97-496b-9561-1f4f3568926b (view SPL)These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets.Methylphenidate HCl Extended-Release Tablets CIIInitial U.S. Approval: 2000prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-01-212680840816, 680840829, 680840833, 680840890
51a88218c-5b18-4220-8f56-526de1a276cd (view SPL)These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA (methylphenidate HCl) Extended-Release Tablets CIIInitial U.S. Approval: 2000prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-1114504580585, 504580586, 504580587, 504580588
62bfb390f-ba99-4d21-8a9e-50fa8ec217c0 (view SPL)These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets. Methylphenidate HCl Extended-Release Tablets CII Initial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-05-161548686262, 548686261
73d1f5aff-5d39-496c-b5ed-7f3c70ec641c (view SPL)These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets.METHYLPHENIDATEhydrochloride extended-release tablets, USP for oral useCII Initial U.S. Approval: 2000prescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.2015-05-1517621750310, 621750311, 621750312, 621750313
84e50d72b-9437-4a23-b2f3-f7a43ad3934e (view SPL)Methylphenidate HClprescriptionHuman PrescriptionSandoz Inc2013-12-018007815754, 007815748, 007815749, 007815753Methylphenidate Oral Tablet
9739bbd64-d9e1-4771-967b-a2cd08f4eaf5 (view SPL)Metadate ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) CIIprescriptionHuman PrescriptionCelltech Pharmaceuticals, Inc.2014-01-069530140594
10981a2ad8-33f7-4678-9162-9df9685bd4a6 (view SPL)METHYLPHENIDATE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg, and 20 mg METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP 10 mg and 20 mg Rx only CII Prescribing InformationprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-1829004061445, 004061473, 004061142, 004061144, 004061146Methylphenidate Oral Tablet
11b1b0f2ff-d9df-42ab-b471-226ecf97e075 (view SPL)These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP safely and effectively. See full prescribing information for methylphenidate hydrochloride extended-release tablets. Methylphenidate Hydrochloride Extended-Release Tablets USP, CII Initial U.S. Approval: 2000prescriptionHuman PrescriptionMallinckrodt, Inc.2015-06-2618004060127, 004060136, 004060154
12be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d (view SPL)prescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2015-08-045107020075, 107020076
13c0bf0835-6a2f-4067-a158-8b86c4b0668a (view SPL)RitalinprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-04-1716000780442, 000780439, 000780440, 000780441Methylphenidate Oral Tablet
14cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 (view SPL)Methylphenidate HCL tablets USP (5 mg, 10 mg, and 20 mg) Methylphenidate HCL ER tablets USP (10 mg and 20 mg)prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290579, 604290580, 604290576, 604290577, 604290578Methylphenidate Oral Tablet
15f63155b9-ea71-4a30-be32-37173f87bcbf (view SPL)These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA (methylphenidate HCl) Extended-Release Tablets CIIInitial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-011548684489, 548684759, 548684789, 548684957
16f931d3af-c32a-4406-8799-9b097f41594b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-162548683454

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII