Methylphenidate Oral Tablet

Brand(s)
Ritalin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Camber Pharmaceuticals, Inc. (2015-10-04)
Oldest Current Product
1955-12-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\METHYLPHENIDATE
FDAOB
ORAL\TABLET\METHYLPHENIDATE HYDROCHLORIDE
SPL Active
ORAL\TABLET\METHYLPHENIDATE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\METHYLPHENIDATE

product(s) by strength(s)

methylphenidate hydrochloride 10 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1006034577Qualitest PharmaceuticalsMETHYLPHENIDATE HYDROCHLORIDEORALTABLETe6f6e86b-01f4-42eb-9054-42c8be1797c8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061144ANDAMallinckrodt, Inc.2011-03-18METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040300981a2ad8-33f7-4678-9162-9df9685bd4a6
2005915883ANDAWatson Laboratories, Inc.1997-08-29METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040220a7713510-2a7c-4c34-9fc2-a96fcdd52891
3007815749NDA AUTHORIZED GENERICSandoz Inc1955-12-31METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA0101874e50d72b-9437-4a23-b2f3-f7a43ad3934e
4317220174ANDACamber Pharmaceuticals, Inc.2015-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA207416778190da-1528-4def-94bf-ee23ee5268a5
5530140530ANDACelltech Pharmaceuticals, Inc.1977-12-23METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA085799f04e8194-7077-42cf-99ee-b61e42a76cf0
6576640229ANDACaraco Pharmaceutical Laboratories, Ltd.2013-08-16METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0907101a89b390-0cd5-45cb-9e70-20de44652c56
7647200238ANDACorepharma, Llc2014-04-07METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0911595eeec304-3f8c-4907-90c5-0a8224a636a2
8655800530ANDAUpstate Pharma, Llc2014-11-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0857990945cdf5-0c86-45ed-88cd-d4e7eb12ac6e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680733ANDAPhysicians Total Care, Inc.2005-03-24METHYLPHENIDATE HYDROCHLORIDEORALTABLET005915883ANDA040220330e620f-4b7f-4101-91dd-feddb7a823ed
2604290577ANDAGolden State Medical Supply, Inc.2010-05-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061144ANDA040300cc0b862e-1c28-4adb-b9b7-e83ef5152cb6
3636293279ANDABryant Ranch Prepack2010-02-01METHYLPHENIDATE HYDROCHLORIDEORALTABLET00406112201ANDA0403000fcdbdb5-4b27-4ef8-aa1c-b72d355def41
4680840823ANDAAmerican Health Packaging2014-08-19METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061144ANDA040300eb9b7377-d918-43fb-8e82-d14c85ed64a8

methylphenidate hydrochloride 20 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1006034578Qualitest PharmaceuticalsMETHYLPHENIDATE HYDROCHLORIDEORALTABLETe6f6e86b-01f4-42eb-9054-42c8be1797c8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061146ANDAMallinckrodt, Inc.2011-03-18METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040300981a2ad8-33f7-4678-9162-9df9685bd4a6
2005915884ANDAWatson Laboratories, Inc.1997-08-29METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040220a7713510-2a7c-4c34-9fc2-a96fcdd52891
3007815753NDA AUTHORIZED GENERICSandoz Inc1955-12-31METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA0101874e50d72b-9437-4a23-b2f3-f7a43ad3934e
4317220175ANDACamber Pharmaceuticals, Inc.2015-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA207416778190da-1528-4def-94bf-ee23ee5268a5
5530140532ANDACelltech Pharmaceuticals, Inc.1979-04-04METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA086428f04e8194-7077-42cf-99ee-b61e42a76cf0
6576640230ANDACaraco Pharmaceutical Laboratories, Ltd.2013-08-16METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0907101a89b390-0cd5-45cb-9e70-20de44652c56
7647200239ANDACorepharma, Llc2014-04-07METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0911595eeec304-3f8c-4907-90c5-0a8224a636a2
8655800532ANDAUpstate Pharma, Llc2014-11-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0864280945cdf5-0c86-45ed-88cd-d4e7eb12ac6e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990844ANDALake Erie Medical Dba Quality Care Products Llc2010-09-15METHYLPHENIDATE HYDROCHLORIDEORALTABLET005915884ANDA040220466e9901-b581-47ce-bafb-33723ead655f
2548682762RitalinNDAPhysicians Total Care, Inc.2000-03-10METHYLPHENIDATE HYDROCHLORIDEORALTABLET000780441NDA010187cd83fc91-47a3-4be4-9727-caf9ec0371e8
3548682974ANDAPhysicians Total Care, Inc.2007-10-16METHYLPHENIDATE HYDROCHLORIDEORALTABLET005915884ANDA040220330e620f-4b7f-4101-91dd-feddb7a823ed
4604290578ANDAGolden State Medical Supply, Inc.2010-05-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061146ANDA040300cc0b862e-1c28-4adb-b9b7-e83ef5152cb6
5636293166NDA AUTHORIZED GENERICBryant Ranch Prepack1955-12-31METHYLPHENIDATE HYDROCHLORIDEORALTABLET007815753NDA01018788852b48-44eb-2c21-5f85-fd2b66376b80
6680840860ANDAAmerican Health Packaging2014-08-19METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061146ANDA040300eb9b7377-d918-43fb-8e82-d14c85ed64a8

methylphenidate hydrochloride 5 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1006034576Qualitest PharmaceuticalsMETHYLPHENIDATE HYDROCHLORIDEORALTABLETe6f6e86b-01f4-42eb-9054-42c8be1797c8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061142ANDAMallinckrodt, Inc.2011-03-18METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040300981a2ad8-33f7-4678-9162-9df9685bd4a6
2005915882ANDAWatson Laboratories, Inc.1997-08-29METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA040220a7713510-2a7c-4c34-9fc2-a96fcdd52891
3007815748NDA AUTHORIZED GENERICSandoz Inc1955-12-31METHYLPHENIDATE HYDROCHLORIDEORALTABLETNDA0101874e50d72b-9437-4a23-b2f3-f7a43ad3934e
4317220173ANDACamber Pharmaceuticals, Inc.2015-10-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA207416778190da-1528-4def-94bf-ee23ee5268a5
5530140531ANDACelltech Pharmaceuticals, Inc.1979-04-04METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA086429f04e8194-7077-42cf-99ee-b61e42a76cf0
6576640228ANDACaraco Pharmaceutical Laboratories, Ltd.2013-08-16METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0907101a89b390-0cd5-45cb-9e70-20de44652c56
7647200237ANDACorepharma, Llc2014-04-07METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0911595eeec304-3f8c-4907-90c5-0a8224a636a2
8655800531ANDAUpstate Pharma, Llc2014-11-01METHYLPHENIDATE HYDROCHLORIDEORALTABLETANDA0864290945cdf5-0c86-45ed-88cd-d4e7eb12ac6e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900837ANDAStat Rx Usa Llc1997-08-29METHYLPHENIDATE HYDROCHLORIDEORALTABLET005915882ANDA040220d356f9f6-d094-478d-bf79-7781490588cc
2548681704ANDAPhysicians Total Care, Inc.2009-05-14METHYLPHENIDATE HYDROCHLORIDEORALTABLET005915882ANDA040220330e620f-4b7f-4101-91dd-feddb7a823ed
3548681706RitalinNDAPhysicians Total Care, Inc.1955-12-312011-06-30METHYLPHENIDATE HYDROCHLORIDEORALTABLET000780439NDA010187cd83fc91-47a3-4be4-9727-caf9ec0371e8
4604290576ANDAGolden State Medical Supply, Inc.2010-05-20METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061142ANDA040300cc0b862e-1c28-4adb-b9b7-e83ef5152cb6
5680840805ANDAAmerican Health Packaging2014-08-19METHYLPHENIDATE HYDROCHLORIDEORALTABLET004061142ANDA040300eb9b7377-d918-43fb-8e82-d14c85ed64a8

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040220METHYLPHENIDATE HYDROCHLORIDEACTAVIS LABORATORIES FL INC1997-08-29ANDA040220_001, ANDA040220_002, ANDA040220_003Methylphenidate Extended Release Oral Tablet
2ANDA040300METHYLPHENIDATE HYDROCHLORIDEMALLINCKRODT INC1998-11-27ANDA040300_001, ANDA040300_002, ANDA040300_003Methylphenidate Extended Release Oral Tablet
3ANDA040321METHYLPHENIDATE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2002-02-05ANDA040321_001, ANDA040321_002, ANDA040321_003Methylphenidate Extended Release Oral Tablet
4ANDA040404METHYLPHENIDATE HYDROCHLORIDETrueABLE LABORATORIES INC2001-03-29ANDA040404_001, ANDA040404_002, ANDA040404_003Methylphenidate Extended Release Oral Tablet
5ANDA085799METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA085799_001Methylphenidate Extended Release Oral Tablet
6ANDA086428METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA086428_001Methylphenidate Extended Release Oral Tablet
7ANDA086429METHYLPHENIDATE HYDROCHLORIDEUCB INCANDA086429_001Methylphenidate Extended Release Oral Tablet
8ANDA090710METHYLPHENIDATE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2012-03-15ANDA090710_001, ANDA090710_002, ANDA090710_003Methylphenidate Extended Release Oral Tablet
9ANDA091159METHYLPHENIDATE HYDROCHLORIDECOREPHARMA LLC2014-03-12ANDA091159_001, ANDA091159_002, ANDA091159_003Methylphenidate Extended Release Oral Tablet
10ANDA202892METHYLPHENIDATE HYDROCHLORIDEVINTAGE PHARMACEUTICALS2014-09-23ANDA202892_001, ANDA202892_002, ANDA202892_003Methylphenidate Extended Release Oral Tablet
11ANDA207416METHYLPHENIDATE HYDROCHLORIDEASCENT PHARMACEUTICALS INC2015-09-22ANDA207416_001, ANDA207416_002, ANDA207416_003Methylphenidate Extended Release Oral Tablet
12NDA010187RITALINNOVARTIS PHARMACEUTICALS CORPNDA010187_003, NDA010187_006, NDA010187_010Methylphenidate Extended Release Oral Tablet

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
7ANDA040321_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
8ANDA040321_002discontinuedMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
9ANDA040321_003discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalse2002-02-05METHYLPHENIDATE HYDROCHLORIDE
10ANDA040404_001discontinuedMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
11ANDA040404_002discontinuedMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
12ANDA040404_003discontinuedMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalse2001-03-29METHYLPHENIDATE HYDROCHLORIDE
13ANDA085799_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
14ANDA086428_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
15ANDA086429_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseABMETHYLPHENIDATE HYDROCHLORIDE
16ANDA090710_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
17ANDA090710_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
18ANDA090710_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2012-03-15METHYLPHENIDATE HYDROCHLORIDE
19ANDA091159_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
20ANDA091159_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
21ANDA091159_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2014-03-12METHYLPHENIDATE HYDROCHLORIDE
22ANDA202892_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
23ANDA202892_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
24ANDA202892_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2014-09-23METHYLPHENIDATE HYDROCHLORIDE
25ANDA207416_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
26ANDA207416_002RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
27ANDA207416_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2015-09-22METHYLPHENIDATE HYDROCHLORIDE
28NDA010187_003RXMETHYLPHENIDATE HYDROCHLORIDE (5MG)ORALTABLETFalseABRITALIN
29NDA010187_006RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALTABLETFalseABRITALIN
30NDA010187_010RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALTABLETTrueABRITALIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10945cdf5-0c86-45ed-88cd-d4e7eb12ac6e (view SPL)METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CIIprescriptionHuman PrescriptionUpstate Pharma, Llc2015-08-282655800530, 655800531, 655800532
20fcdbdb5-4b27-4ef8-aa1c-b72d355def41 (view SPL)methylphenidate hydrochloride 10mg TabletprescriptionHuman PrescriptionBryant Ranch Prepackrepack2010-02-011636293279
31a89b390-0cd5-45cb-9e70-20de44652c56 (view SPL)CIIRx OnlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2015-05-078576640228, 576640229, 576640230
4330e620f-4b7f-4101-91dd-feddb7a823ed (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-167548680733, 548681704, 548682974
5466e9901-b581-47ce-bafb-33723ead655f (view SPL)Methylphenidate Hydrochloride 20 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-08-103987499990844
64e50d72b-9437-4a23-b2f3-f7a43ad3934e (view SPL)Methylphenidate HClprescriptionHuman PrescriptionSandoz Inc2013-12-018007815748, 007815749, 007815753, 007815754Methylphenidate Extended Release Oral Tablet
75eeec304-3f8c-4907-90c5-0a8224a636a2 (view SPL)Methylphenidate Hydrochloride Tablets, USP5 mg, 10 mg and 20 mgCIIRx onlyprescriptionHuman PrescriptionCorepharma, Llc2015-03-097647200237, 647200238, 647200239
8778190da-1528-4def-94bf-ee23ee5268a5 (view SPL)Methylphenidate Hydrochloride Tablets, USP CIIRx onlyPrescribing InformationprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.manufacture2015-10-041317220173, 317220174, 317220175
988852b48-44eb-2c21-5f85-fd2b66376b80 (view SPL)Methylphenidate HClprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293166
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, MANUFACTURE2015-06-1829004061142, 004061144, 004061146, 004061445, 004061473Methylphenidate Extended Release Oral Tablet
11a7713510-2a7c-4c34-9fc2-a96fcdd52891 (view SPL)Methylphenidate HCl Tablets USP CII Revised: January 2014 Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-01-0112005915882, 005915883, 005915884
12c0bf0835-6a2f-4067-a158-8b86c4b0668a (view SPL)RitalinprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-04-1716000780439, 000780440, 000780441, 000780442Methylphenidate Extended Release Oral Tablet
13cc0b862e-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, REPACK2012-01-091604290576, 604290577, 604290578, 604290579, 604290580Methylphenidate Extended Release Oral Tablet
14cd83fc91-47a3-4be4-9727-caf9ec0371e8 (view SPL)RitalinprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-201548681706, 548682762
15d356f9f6-d094-478d-bf79-7781490588cc (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2009-05-221165900837
16e6f6e86b-01f4-42eb-9054-42c8be1797c8 (view SPL)METHYLPHENIDATE HYDROCHLORIDE TABLETS USP Cll 5 mg, 10 mg, and 20 mg Rx only Prescribing InformationprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-06-227006034576, 006034577, 006034578
17eb9b7377-d918-43fb-8e82-d14c85ed64a8 (view SPL)Methylphenidate Hydrochloride Tablets USP CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-072680840805, 680840823, 680840860
18f04e8194-7077-42cf-99ee-b61e42a76cf0 (view SPL)METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CIIprescriptionHuman PrescriptionCelltech Pharmaceuticals, Inc.2014-01-069530140530, 530140531, 530140532

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