Carbidopa / Levodopa Extended Release Oral Tablet

Brand(s)
Sinemet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2014-07-17)
Oldest Current Product
1991-05-30
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\CARBIDOPA:LEVODOPA
FDAOB
ORAL\TABLET, EXTENDED RELEASE\CARBIDOPA: LEVODOPA
SPL Active
ORAL\TABLET, EXTENDED RELEASE\CARBIDOPA: LEVODOPA
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\CARBIDOPA ANHYDROUS: LEVODOPA
ORAL\TABLET, EXTENDED RELEASE\CARBIDOPA: CARBIDOPA ANHYDROUS: LEVODOPA
ORAL\TABLET, EXTENDED RELEASE\CARBIDOPA: LEVODOPA

product(s) by strength(s)

carbidopa 25 mg / levodopa 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063918SinemetNDAMerck Sharp & Dohme Corp.1991-05-30CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASENDA01985669e575b9-f8a5-494f-b736-2520ef505cb0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001153922ANDAGlobal Pharmaceuticals2004-05-14CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA0765210d31ce9a-e5bf-4968-8108-a137898ac262
2003780088ANDAMylan Pharmaceuticals Inc.2000-04-26CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA075091aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a
3167290078ANDAAccord Healthcare Inc.2013-06-13CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA2023235217a6ec-cc26-4acc-b2da-17f6545c3b60
4627560461ANDASun Pharmaceutical Industries Limited2007-08-23CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA077828d2a64f14-f638-49d9-8a96-cb7ae46ac3ea
5680010171ANDABluepoint Laboratories2014-01-22CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA20232358a6e76a-f99f-4f0c-9d83-a55a30edda97

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154569ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-18CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE003780088ANDA075091d7c6da26-42a7-4743-be02-3a233434eef2
2510790978ANDAMylan Institutional Inc.2004-05-14CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE003780088ANDA07509116f9e4d1-6953-4d4f-b4cf-ad95a856ac25
3548685659ANDAPhysicians Total Care, Inc.2006-08-18CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE627560461ANDA077828abff005f-23fc-4d1e-b469-88aa07589a43
4551544568ANDACardinal Health2007-08-23CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE627560461ANDA077828043db807-8381-4df8-b3a3-825988d63ef5
5606870174ANDAAmerican Health Packaging2015-10-01CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE680010171ANDA2023234e95f5a1-dba0-443d-b5d5-6946508abd2c
6680840281ANDAAmerican Health Packaging2013-07-12CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE627560461ANDA07782811587fa6-dc2c-44a5-85c6-85ec40c6b9b1

carbidopa 50 mg / levodopa 200 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063919SinemetNDAMerck Sharp & Dohme Corp.1991-05-30CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASENDA01985669e575b9-f8a5-494f-b736-2520ef505cb0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001153911ANDAGlobal Pharmaceuticals2004-05-14CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA0765210d31ce9a-e5bf-4968-8108-a137898ac262
2003780094ANDAMylan Pharmaceuticals Inc.1999-10-06CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA075091aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a
3167290079ANDAAccord Healthcare Inc.2013-06-13CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA2023235217a6ec-cc26-4acc-b2da-17f6545c3b60
4627560457ANDASun Pharmaceutical Industries Limited2007-08-23CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA077828d2a64f14-f638-49d9-8a96-cb7ae46ac3ea
5680010172ANDABluepoint Laboratories2014-01-22CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASEANDA20232358a6e76a-f99f-4f0c-9d83-a55a30edda97

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154568ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-18CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE003780094ANDA075091d7c6da26-42a7-4743-be02-3a233434eef2
2510790923ANDAMylan Institutional Inc.2004-05-14CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE003780094ANDA07509116f9e4d1-6953-4d4f-b4cf-ad95a856ac25
3548685776ANDAPhysicians Total Care, Inc.2007-06-08CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE627560457ANDA077828abff005f-23fc-4d1e-b469-88aa07589a43
4606870181ANDAAmerican Health Packaging2015-10-01CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE680010172ANDA2023234e95f5a1-dba0-443d-b5d5-6946508abd2c
5680840282ANDAAmerican Health Packaging2013-07-12CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE627560457ANDA07782811587fa6-dc2c-44a5-85c6-85ec40c6b9b1
6762370259ANDAMckesson Contract Packaging2012-02-08CARBIDOPA, LEVODOPAORALTABLET, EXTENDED RELEASE003780094ANDA075091b4b398bc-399c-4832-adef-baf2019c633d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075091CARBIDOPA AND LEVODOPAMYLAN PHARMACEUTICALS INC1999-09-30ANDA075091_001, ANDA075091_002
2ANDA076212CARBIDOPA AND LEVODOPAAPOTEX INC2004-06-16ANDA076212_001, ANDA076212_002
3ANDA076521CARBIDOPA AND LEVODOPAIMPAX LABORATORIES INC2004-05-14ANDA076521_001, ANDA076521_002
4ANDA076663CARBIDOPA AND LEVODOPATrueKV PHARMACEUTICAL CO2004-06-24ANDA076663_001
5ANDA077828CARBIDOPA AND LEVODOPASUN PHARMACEUTICAL INDUSTRIES LTD2007-08-23ANDA077828_001, ANDA077828_002
6ANDA202323CARBIDOPA AND LEVODOPAACCORD HEALTHCARE INC2013-02-08ANDA202323_001, ANDA202323_002
7NDA019856SINEMET CRMERCK SHARP AND DOHME CORP1991-05-30NDA019856_001, NDA019856_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075091_001RXLEVODOPA (200MG), CARBIDOPA (50MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-09-30CARBIDOPA AND LEVODOPA
2ANDA075091_002RXLEVODOPA (100MG), CARBIDOPA (25MG)ORALTABLET, EXTENDED RELEASEFalseAB2000-04-21CARBIDOPA AND LEVODOPA
3ANDA076212_001RXLEVODOPA (100MG), CARBIDOPA (25MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-06-16CARBIDOPA AND LEVODOPA
4ANDA076212_002RXCARBIDOPA (50MG), LEVODOPA (200MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-06-16CARBIDOPA AND LEVODOPA
5ANDA076521_001RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-05-14CARBIDOPA AND LEVODOPA
6ANDA076521_002RXLEVODOPA (200MG), CARBIDOPA (50MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-05-14CARBIDOPA AND LEVODOPA
7ANDA076663_001discontinuedLEVODOPA (200MG), CARBIDOPA (50MG)ORALTABLET, EXTENDED RELEASEFalse2004-06-24CARBIDOPA AND LEVODOPA
8ANDA077828_001RXLEVODOPA (100MG), CARBIDOPA (25MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-08-23CARBIDOPA AND LEVODOPA
9ANDA077828_002RXCARBIDOPA (50MG), LEVODOPA (200MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-08-23CARBIDOPA AND LEVODOPA
10ANDA202323_001RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2013-02-08CARBIDOPA AND LEVODOPA
11ANDA202323_002RXLEVODOPA (200MG), CARBIDOPA (50MG)ORALTABLET, EXTENDED RELEASEFalseAB2013-02-08CARBIDOPA AND LEVODOPA
12NDA019856_001RXCARBIDOPA (50MG), LEVODOPA (200MG)ORALTABLET, EXTENDED RELEASETrueAB1991-05-30SINEMET CR
13NDA019856_002RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLET, EXTENDED RELEASEFalseAB1992-12-24SINEMET CR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1043db807-8381-4df8-b3a3-825988d63ef5 (view SPL)Carbidopa and Levodopa Extended-Release TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-032551544568
20d31ce9a-e5bf-4968-8108-a137898ac262 (view SPL)Carbidopa-Levodopa Extended-release Tablets, 25 mg/100 mg and 50 mg/200 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2012-01-192001153911, 001153922
311587fa6-dc2c-44a5-85c6-85ec40c6b9b1 (view SPL)Carbidopa and Levodopa Extended-release TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-063680840281, 680840282
416f9e4d1-6953-4d4f-b4cf-ad95a856ac25 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-05-014510790923, 510790978
54e95f5a1-dba0-443d-b5d5-6946508abd2c (view SPL)Carbidopa and Levodopa Extended-Release TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-161606870174, 606870181
65217a6ec-cc26-4acc-b2da-17f6545c3b60 (view SPL)Carbidopa and Levodopa Extended-Release Tablets Rx onlyprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-01-025167290078, 167290079
758a6e76a-f99f-4f0c-9d83-a55a30edda97 (view SPL)prescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-05-133680010171, 680010172
869e575b9-f8a5-494f-b736-2520ef505cb0 (view SPL)SINEMET CR (carbidopa levodopa) Sustained-Release TabletsprescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2014-07-175000063918, 000063919
9aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-09-307003780088, 003780094
10abff005f-23fc-4d1e-b469-88aa07589a43 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-083548685659, 548685776
11b4b398bc-399c-4832-adef-baf2019c633d (view SPL)prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-05-101762370259
12d2a64f14-f638-49d9-8a96-cb7ae46ac3ea (view SPL)Carbidopa and Levodopa Extended-release TabletsprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-135627560457, 627560461
13d7c6da26-42a7-4743-be02-3a233434eef2 (view SPL)CARBIDOPAAND LEVODOPA EXTENDED -RELEASE TABLETS, USP 25 mg/100 mg and 50 mg/200 mg Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-11-0214006154568, 006154569

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