Methylphenidate Extended Release Oral Capsule

Brand(s)
Aptensio, Metadate, Ritalin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-07-07)
Oldest Current Product
2002-06-05
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\METHYLPHENIDATE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
ORAL\CAPSULE\METHYLPHENIDATE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\METHYLPHENIDATE
ORAL\CAPSULE\METHYLPHENIDATE

product(s) by strength(s)

24 hr methylphenidate hydrochloride 10 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428580401AptensioNDARhodes Pharmaceuticals L.P.2015-04-17METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA2058315adedc01-ebf0-11e3-ac10-0800200c9a66
2530140579MetadateNDACelltech Pharmaceuticals, Inc.2003-08-12METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259a6aedc40-5725-4bd3-9037-033746e8599e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935295ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA077707b7941137-6f70-4501-9428-de726b3e7ae8
2004061810ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
3621750151NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2003-08-12METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685397MetadateNDAPhysicians Total Care, Inc.2005-08-26METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE530140579NDA021259be6f8d00-9281-4f67-b8fc-3de58a4d14f4
2606870140ANDAAmerican Health Packaging2015-03-31METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE000935295ANDA0777070d5d588a-88d1-4b74-9604-0c3cd7eda9d9

24 hr methylphenidate hydrochloride 15 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428580402AptensioNDARhodes Pharmaceuticals L.P.2015-04-17METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA2058315adedc01-ebf0-11e3-ac10-0800200c9a66

24 hr methylphenidate hydrochloride 20 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428580403AptensioNDARhodes Pharmaceuticals L.P.2015-04-17METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA2058315adedc01-ebf0-11e3-ac10-0800200c9a66
2530140580MetadateNDACelltech Pharmaceuticals, Inc.2003-02-18METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259a6aedc40-5725-4bd3-9037-033746e8599e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935296ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA077707b7941137-6f70-4501-9428-de726b3e7ae8
2000935346ANDATeva Pharmaceuticals Usa Inc2012-07-16METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA079031034fb7cd-e183-475e-8beb-64fd88facc8f
3004061820ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
4621750152NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2003-02-18METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72
5677670200ANDAActavis South Atlantic Llc2012-01-03METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078458ecd88778-0540-4f6f-9bbd-61d42f1a9515

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684718MetadateNDAPhysicians Total Care, Inc.2002-12-23METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE530140580NDA021259be6f8d00-9281-4f67-b8fc-3de58a4d14f4
2680840902ANDAAmerican Health Packaging2014-12-01METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE677670200ANDA078458a4ebf74d-4218-44cd-99dc-497aedd93291

24 hr methylphenidate hydrochloride 30 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780371RitalinNDANovartis Pharmaceuticals Corporation2002-06-05METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021284effd952d-ac94-47bb-b107-589a4934dcca
2428580404AptensioNDARhodes Pharmaceuticals L.P.2015-04-17METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA2058315adedc01-ebf0-11e3-ac10-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935297ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA077707b7941137-6f70-4501-9428-de726b3e7ae8
2000935347ANDATeva Pharmaceuticals Usa Inc2012-07-16METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA079031034fb7cd-e183-475e-8beb-64fd88facc8f
3004061830ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
4621750153NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2003-07-22METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72
5677670201ANDAActavis South Atlantic Llc2012-01-03METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078458ecd88778-0540-4f6f-9bbd-61d42f1a9515

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680668MetadateNDAPhysicians Total Care, Inc.2005-08-26METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE530140581NDA021259be6f8d00-9281-4f67-b8fc-3de58a4d14f4
2606870151ANDAAmerican Health Packaging2015-03-31METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE000935297ANDA0777070d5d588a-88d1-4b74-9604-0c3cd7eda9d9

24 hr methylphenidate hydrochloride 40 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428580405AptensioNDARhodes Pharmaceuticals L.P.2015-04-17METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA2058315adedc01-ebf0-11e3-ac10-0800200c9a66
2530140582MetadateNDACelltech Pharmaceuticals, Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259a6aedc40-5725-4bd3-9037-033746e8599e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935298ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078873b7941137-6f70-4501-9428-de726b3e7ae8
2000935348ANDATeva Pharmaceuticals Usa Inc2012-07-16METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA079031034fb7cd-e183-475e-8beb-64fd88facc8f
3004061840ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
4621750154NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72
5677670202ANDAActavis South Atlantic Llc2012-01-03METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078458ecd88778-0540-4f6f-9bbd-61d42f1a9515

24 hr methylphenidate hydrochloride 50 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1530140583MetadateNDACelltech Pharmaceuticals, Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259a6aedc40-5725-4bd3-9037-033746e8599e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935292ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078873b7941137-6f70-4501-9428-de726b3e7ae8
2004061850ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
3621750155NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686234MetadateNDAPhysicians Total Care, Inc.2011-03-02METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE530140583NDA021259be6f8d00-9281-4f67-b8fc-3de58a4d14f4

24 hr methylphenidate hydrochloride 60 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780658RitalinNDANovartis Pharmaceuticals Corporation2015-02-01METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021284effd952d-ac94-47bb-b107-589a4934dcca
2530140584MetadateNDACelltech Pharmaceuticals, Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259a6aedc40-5725-4bd3-9037-033746e8599e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935293ANDATeva Pharmaceuticals Usa Inc2012-09-27METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078873b7941137-6f70-4501-9428-de726b3e7ae8
2004061860ANDAMallinckrodt, Inc.2015-09-29METHYLPHENIDATE HYDROCHLORIDEORALCAPSULEANDA2035839e11e093-4ff3-4bed-8fe9-3ee460b47303
3621750156NDA AUTHORIZED GENERICKremers Urban Pharmaceuticals Inc.2006-03-21METHYLPHENIDATE HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA021259fe0290cd-d183-4a29-a876-d3bd421d9e72

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA077707METHYLPHENIDATE HYDROCHLORIDETEVA PHARMACEUTICALS USA2012-07-19ANDA077707_001, ANDA077707_002, ANDA077707_003
2ANDA078458METHYLPHENIDATE HYDROCHLORIDEWATSON LABORATORIES INC2011-12-01ANDA078458_001, ANDA078458_002, ANDA078458_003
3ANDA078873METHYLPHENIDATE HYDROCHLORIDETEVA PHARMACEUTICALS USA2012-07-19ANDA078873_001, ANDA078873_002, ANDA078873_003
4ANDA079031METHYLPHENIDATE HYDROCHLORIDEBARR LABORATORIES INC2012-07-13ANDA079031_001, ANDA079031_002, ANDA079031_003, ANDA079031_004
5ANDA203583METHYLPHENIDATE HYDROCHLORIDEMALLINCKRODT INC2015-09-29ANDA203583_001, ANDA203583_002, ANDA203583_003, ANDA203583_004, ANDA203583_005, ANDA203583_006
6NDA021259METADATE CDUCB INC2001-04-03p6344215, SUBSTANCENDA021259_001, NDA021259_002, NDA021259_003, NDA021259_004, NDA021259_005, NDA021259_006
7NDA021284RITALIN LANOVARTIS PHARMACEUTICALS CORP2002-06-05p5837284, SUBSTANCE
p7431944, SUBSTANCE
p6228398, TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES, SUBSTANCE
p6635284, TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH PROVIDES ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG, SUBSTANCE
NDA021284_001, NDA021284_002, NDA021284_003, NDA021284_004, NDA021284_005
8NDA205831APTENSIO XRRHODES PHARMACEUTICALS LP2015-04-17p7247318, SUBSTANCE
p7083808, SUBSTANCE
p8580310, SUBSTANCE
p9066869, SUBSTANCE
p6419960, SUBSTANCE
p7438930, SUBSTANCE
NEW PRODUCT [2018-04-17]NDA205831_001, NDA205831_002, NDA205831_003, NDA205831_004, NDA205831_005, NDA205831_006, NDA205831_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077707_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
2ANDA077707_002RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
3ANDA077707_003RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
4ANDA078458_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-12-01METHYLPHENIDATE HYDROCHLORIDE
5ANDA078458_002RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-12-01METHYLPHENIDATE HYDROCHLORIDE
6ANDA078458_003RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-12-01METHYLPHENIDATE HYDROCHLORIDE
7ANDA078873_001RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
8ANDA078873_002RXMETHYLPHENIDATE HYDROCHLORIDE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
9ANDA078873_003RXMETHYLPHENIDATE HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22012-07-19METHYLPHENIDATE HYDROCHLORIDE
10ANDA079031_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12012-07-13METHYLPHENIDATE HYDROCHLORIDE
11ANDA079031_002RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12012-07-13METHYLPHENIDATE HYDROCHLORIDE
12ANDA079031_003RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12012-07-13METHYLPHENIDATE HYDROCHLORIDE
13ANDA079031_004RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-10-15METHYLPHENIDATE HYDROCHLORIDE
14ANDA203583_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
15ANDA203583_002RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
16ANDA203583_003RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
17ANDA203583_004RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
18ANDA203583_005RXMETHYLPHENIDATE HYDROCHLORIDE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
19ANDA203583_006RXMETHYLPHENIDATE HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22015-09-29METHYLPHENIDATE HYDROCHLORIDE
20NDA021259_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22001-04-03METADATE CD
21NDA021259_002RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22003-06-19METADATE CD
22NDA021259_003RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22003-05-27METADATE CD
23NDA021259_004RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22006-02-19METADATE CD
24NDA021259_005RXMETHYLPHENIDATE HYDROCHLORIDE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB22006-02-19METADATE CD
25NDA021259_006RXMETHYLPHENIDATE HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASETrueAB22006-02-19METADATE CD
26NDA021284_001RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12002-06-05RITALIN LA
27NDA021284_002RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12002-06-05RITALIN LA
28NDA021284_003RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12002-06-05RITALIN LA
29NDA021284_004RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12004-04-10RITALIN LA
30NDA021284_005RXMETHYLPHENIDATE HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASETrue2014-10-27RITALIN LA
31NDA205831_001RXMETHYLPHENIDATE HYDROCHLORIDE (10MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
32NDA205831_002RXMETHYLPHENIDATE HYDROCHLORIDE (15MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
33NDA205831_003RXMETHYLPHENIDATE HYDROCHLORIDE (20MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
34NDA205831_004RXMETHYLPHENIDATE HYDROCHLORIDE (30MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
35NDA205831_005RXMETHYLPHENIDATE HYDROCHLORIDE (40MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
36NDA205831_006RXMETHYLPHENIDATE HYDROCHLORIDE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-04-17APTENSIO XR
37NDA205831_007RXMETHYLPHENIDATE HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASETrue2015-04-17APTENSIO XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5837284 (view patent)2015-12-04NDA021284, NDA021802dexmethylphenidate Extended Release Oral Capsule
2p6228398 (view patent)2019-11-01NDA021284, NDA021802, NDA202880dexmethylphenidate Extended Release Oral Capsule
Hydrocodone Extended Release Oral Capsule
3p6344215 (view patent)2020-10-27NDA021259
4p6419960 (view patent)2019-12-16NDA205831
5p6635284 (view patent)2015-12-04NDA021284, NDA021802dexmethylphenidate Extended Release Oral Capsule
6p7083808 (view patent)2019-12-16NDA205831
7p7247318 (view patent)2019-12-16NDA205831
8p7431944 (view patent)2015-12-04NDA021284, NDA021802dexmethylphenidate Extended Release Oral Capsule
9p7438930 (view patent)2019-12-16NDA205831
10p8580310 (view patent)2019-12-16NDA205831
11p9066869 (view patent)2019-12-16NDA205831

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1034fb7cd-e183-475e-8beb-64fd88facc8f (view SPL)METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES LA CII 5345534653475348 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-053000935346, 000935347, 000935348
20d5d588a-88d1-4b74-9604-0c3cd7eda9d9 (view SPL)Once Daily METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (CD) CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-04-061606870140, 606870151
35adedc01-ebf0-11e3-ac10-0800200c9a66 (view SPL)These highlights do not include all the information needed to use APTENSIO XRsafely and effectively. See full prescribing information for APTENSIO XR. APTENSIO XR(methylphenidate hydrochloride extended-release) Capsules, for oral use. CII Initial U.S. Approval: 1955prescriptionHuman PrescriptionRhodes Pharmaceuticals L.P.ANALYSIS, MANUFACTURE2015-05-125428580401, 428580402, 428580403, 428580404, 428580405, 428580406, 428580407
49e11e093-4ff3-4bed-8fe9-3ee460b47303 (view SPL)Once Daily Methylphenidate HCl Extended-Release Capsules10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg CII Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.2015-04-2210004061810, 004061820, 004061830, 004061840, 004061850, 004061860
5a4ebf74d-4218-44cd-99dc-497aedd93291 (view SPL)Once DailyMethylphenidate HydrochlorideExtended-Release Capsules (LA)CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-12-181680840902
6a6aedc40-5725-4bd3-9037-033746e8599e (view SPL)Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules CIIprescriptionHuman PrescriptionCelltech Pharmaceuticals, Inc.2015-04-2113530140579, 530140580, 530140582, 530140583, 530140584, 530140581
7b7941137-6f70-4501-9428-de726b3e7ae8 (view SPL)Once Daily METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (CD) CIIDISPENSE WITH MEDICATION GUIDE529552965297529852925293Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-07-156000935292, 000935293, 000935295, 000935296, 000935297, 000935298
8be6f8d00-9281-4f67-b8fc-3de58a4d14f4 (view SPL)Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules CIIprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-011548680668, 548684718, 548685397, 548686234
9ecd88778-0540-4f6f-9bbd-61d42f1a9515 (view SPL)Methylphenidate Hydrochloride Extended-Release Capsules (LA) CIIprescriptionHuman PrescriptionActavis South Atlantic LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-12-2612677670200, 677670201, 677670202
10effd952d-ac94-47bb-b107-589a4934dcca (view SPL)Ritalin LAprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-07-0720000780371, 000780658, 000780370, 000780372, 000780424
11fe0290cd-d183-4a29-a876-d3bd421d9e72 (view SPL)Methylphenidate HCl Extended-Release Capsules CD CIIprescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.2015-05-066621750151, 621750152, 621750153, 621750154, 621750155, 621750156

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