Primidone Oral Tablet

Brand(s)
Mysoline
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America (2013-08-27)
Oldest Current Product
1978-12-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PRIMIDONE
FDAOB
ORAL\TABLET\PRIMIDONE
SPL Active
ORAL\TABLET\PRIMIDONE
SPL Moiety
ORAL\TABLET\PRIMIDONE

product(s) by strength(s)

primidone 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1664900691MysolineNDAValeant Pharmaceuticals North America2009-06-24PRIMIDONEORALTABLETNDA009170af593171-dabb-4ea3-b44c-89ed457b2c46

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151031ANDAGlobal Pharmaceuticals2008-02-12PRIMIDONEORALTABLETANDA040717ba3794e3-4d34-41fd-9a66-e24549f17748
2001431484ANDAWest-Ward Pharmaceutical Corp2006-07-01PRIMIDONEORALTABLETANDA04066714a12cc9-0474-48f1-8a6c-7bceda2be8da
3005271231ANDALannett Company, Inc.1978-12-01PRIMIDONEORALTABLETANDA084903a1a817f7-c190-4825-94eb-442f477187e3
4005915321ANDAWatson Laboratories, Inc.2010-06-19PRIMIDONEORALTABLETANDA083551ae0fa704-818e-4423-8e3a-6cc3390cdd7d
5006035372ANDAQualitest Pharmaceuticals2005-02-24PRIMIDONEORALTABLETANDA040586cce71bdb-1018-4f94-90d4-cf3cc804fbb3
6009040560ANDAMajor2005-04-07PRIMIDONEORALTABLETANDA0849033f88b090-5e75-4a74-ab9e-97ec2959e345
7101350522ANDAMarlex Pharmaceuticals Inc2015-05-01PRIMIDONEORALTABLETANDA084903934a6d96-6da2-4fba-bf1f-08e7acbf59bc
8651620545ANDAAmneal Pharmaceuticals2009-12-24PRIMIDONEORALTABLETANDA04086602ba0182-0870-4c0d-a814-a1dc427d47b8

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110476ANDADr. Reddy'S Laboratories Ltd2008-10-03PRIMIDONEORALTABLETANDA040862a4f917f4-2aa2-c3ed-071e-232fa0f125e8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006152521ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2006-07-01PRIMIDONEORALTABLET001431484ANDA040667dc19429e-ddaf-4092-8730-012a1d9f45e7
2006157738ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1978-12-01PRIMIDONEORALTABLET005271231ANDA084903418a70aa-8480-4748-a1a8-af39f4962bf0
3009046207ANDAMajor2009-12-24PRIMIDONEORALTABLET651620545ANDA0408663867bf43-1e1e-40dd-8aad-7e5d4357c10d
4422910511ANDAAvkare, Inc.2008-04-24PRIMIDONEORALTABLET651620545ANDA040866e7a50a67-9653-463e-8c85-315b53f460c8
5502680687ANDAAvpak2011-05-19PRIMIDONEORALTABLET651620545ANDA040866a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b
6548681691ANDAPhysicians Total Care, Inc.2009-07-27PRIMIDONEORALTABLET005271231ANDA084903c7cb2073-9d44-4261-b308-02cd24c1f17a
7680840203ANDAAmerican Health Packaging2007-06-14PRIMIDONEORALTABLET005271231ANDA084903a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11

primidone 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1664900690MysolineNDAValeant Pharmaceuticals North America2009-06-24PRIMIDONEORALTABLETNDA009170af593171-dabb-4ea3-b44c-89ed457b2c46

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151030ANDAGlobal Pharmaceuticals2008-02-12PRIMIDONEORALTABLETANDA040717ba3794e3-4d34-41fd-9a66-e24549f17748
2001431482ANDAWest-Ward Pharmaceutical Corp2006-07-01PRIMIDONEORALTABLETANDA04066714a12cc9-0474-48f1-8a6c-7bceda2be8da
3005271301ANDALannett Company, Inc.2001-05-24PRIMIDONEORALTABLETANDA084903a1a817f7-c190-4825-94eb-442f477187e3
4006035371ANDAQualitest Pharmaceuticals2005-02-24PRIMIDONEORALTABLETANDA040586cce71bdb-1018-4f94-90d4-cf3cc804fbb3
5009045559ANDAMajor2005-04-07PRIMIDONEORALTABLETANDA0849033f88b090-5e75-4a74-ab9e-97ec2959e345
6101350540ANDAMarlex Pharmaceuticals Inc2015-05-01PRIMIDONEORALTABLETANDA084903934a6d96-6da2-4fba-bf1f-08e7acbf59bc
7651620544ANDAAmneal Pharmaceuticals2009-12-24PRIMIDONEORALTABLETANDA04086602ba0182-0870-4c0d-a814-a1dc427d47b8

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110477ANDADr. Reddy'S Laboratories Ltd2008-10-03PRIMIDONEORALTABLETANDA040862a4f917f4-2aa2-c3ed-071e-232fa0f125e8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155591ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2001-05-24PRIMIDONEORALTABLET005271301ANDA084903418a70aa-8480-4748-a1a8-af39f4962bf0
2422910509ANDAAvkare, Inc.2008-04-24PRIMIDONEORALTABLET651620544ANDA040866e7a50a67-9653-463e-8c85-315b53f460c8
3425490680ANDAStat Rx Usa Llc2001-05-24PRIMIDONEORALTABLET005271301ANDA084903ccadc401-fbcd-45e5-9c76-c8307324f638
4502680686ANDAAvpak2011-05-19PRIMIDONEORALTABLET651620544ANDA040866a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b
5548685067ANDAPhysicians Total Care, Inc.2009-01-29PRIMIDONEORALTABLET005271301ANDA084903c7cb2073-9d44-4261-b308-02cd24c1f17a
6551549477ANDACardinal Health2001-05-24PRIMIDONEORALTABLET005271301ANDA0849033efbdc25-e1dc-490d-83d5-969e39dde3e8
7680840202ANDAAmerican Health Packaging2007-06-14PRIMIDONEORALTABLET005271301ANDA084903a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11
8762370229ANDAMckesson Contract Packaging2011-12-27PRIMIDONEORALTABLET005271301ANDA0849034e6e3e52-a978-4550-be38-21e74bda5a6a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040586PRIMIDONEVINTAGE PHARMACEUTICALS INC2005-02-24ANDA040586_001, ANDA040586_002
2ANDA040626PRIMIDONEMUTUAL PHARMACEUTICAL CO INC2005-09-29ANDA040626_001, ANDA040626_002
3ANDA040667PRIMIDONEHIKMA PHARMACEUTICALS LLC2006-07-27ANDA040667_001, ANDA040667_002
4ANDA040717PRIMIDONEIMPAX LABORATORIES INC2008-02-12ANDA040717_001, ANDA040717_002
5ANDA040862PRIMIDONETrueDR REDDYS LABORATORIES LTD2008-10-03ANDA040862_001, ANDA040862_002
6ANDA040866PRIMIDONEAMNEAL PHARMACEUTICAL2008-04-23ANDA040866_001, ANDA040866_002
7ANDA083551PRIMIDONEWATSON LABORATORIES INCANDA083551_001
8ANDA084903PRIMIDONELANNETT CO INCANDA084903_001, ANDA084903_002
9ANDA085052PRIMIDONETrueWATSON LABORATORIES INCANDA085052_001
10NDA009170MYSOLINEVALEANT PHARMACEUTICALS INTERNATIONALNDA009170_002, NDA009170_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040586_001RXPRIMIDONE (50MG)ORALTABLETFalseAB2005-02-24PRIMIDONE
2ANDA040586_002RXPRIMIDONE (250MG)ORALTABLETFalseAB2005-02-24PRIMIDONE
3ANDA040626_001RXPRIMIDONE (50MG)ORALTABLETFalseAB2005-09-29PRIMIDONE
4ANDA040626_002RXPRIMIDONE (250MG)ORALTABLETFalseAB2005-09-29PRIMIDONE
5ANDA040667_001discontinuedPRIMIDONE (50MG)ORALTABLETFalse2006-07-27PRIMIDONE
6ANDA040667_002RXPRIMIDONE (250MG)ORALTABLETFalseAB2006-07-27PRIMIDONE
7ANDA040717_001RXPRIMIDONE (50MG)ORALTABLETFalseAB2008-02-12PRIMIDONE
8ANDA040717_002RXPRIMIDONE (250MG)ORALTABLETFalseAB2008-02-12PRIMIDONE
9ANDA040862_001discontinuedPRIMIDONE (50MG)ORALTABLETFalse2008-10-03PRIMIDONE
10ANDA040862_002discontinuedPRIMIDONE (250MG)ORALTABLETFalse2008-10-03PRIMIDONE
11ANDA040866_001RXPRIMIDONE (50MG)ORALTABLETFalseAB2008-04-23PRIMIDONE
12ANDA040866_002RXPRIMIDONE (250MG)ORALTABLETFalseAB2008-04-23PRIMIDONE
13ANDA083551_001RXPRIMIDONE (250MG)ORALTABLETFalseABPRIMIDONE
14ANDA084903_001RXPRIMIDONE (250MG)ORALTABLETFalseABPRIMIDONE
15ANDA084903_002RXPRIMIDONE (50MG)ORALTABLETFalseAB2001-05-24PRIMIDONE
16ANDA085052_001discontinuedPRIMIDONE (250MG)ORALTABLETFalsePRIMIDONE
17NDA009170_002RXPRIMIDONE (250MG)ORALTABLETFalseABMYSOLINE
18NDA009170_003RXPRIMIDONE (50MG)ORALTABLETTrueABMYSOLINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102ba0182-0870-4c0d-a814-a1dc427d47b8 (view SPL)Primidone Tablets, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2012-08-1510651620544, 651620545
214a12cc9-0474-48f1-8a6c-7bceda2be8da (view SPL)Primidone Tablets, USPRev. 12/11prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2011-12-144001431482, 001431484
33867bf43-1e1e-40dd-8aad-7e5d4357c10d (view SPL)Primidone Tablets, USPprescriptionHuman PrescriptionMajorRELABEL, REPACK2011-04-074009046207
43efbdc25-e1dc-490d-83d5-969e39dde3e8 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-10-052551549477
53f88b090-5e75-4a74-ab9e-97ec2959e345 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionMajor2012-07-111009040560, 009045559
6418a70aa-8480-4748-a1a8-af39f4962bf0 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2014-12-186006155591, 006157738
74e6e3e52-a978-4550-be38-21e74bda5a6a (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-01-111762370229
8934a6d96-6da2-4fba-bf1f-08e7acbf59bc (view SPL)PrimidoneprescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-05-281101350522, 101350540
9a1a817f7-c190-4825-94eb-442f477187e3 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-226005271231, 005271301
10a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-292680840202, 680840203
11a4f917f4-2aa2-c3ed-071e-232fa0f125e8 (view SPL)Primidone Tablet USPprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2010-03-192551110476, 551110477
12a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b (view SPL)Primidone Tablets, USPprescriptionHuman PrescriptionAvpak2015-02-128502680686, 502680687
13ae0fa704-818e-4423-8e3a-6cc3390cdd7d (view SPL)Primidone Tablets USP Revised: October 2010 Rx Only 190832-2prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-04-1313005915321
14af593171-dabb-4ea3-b44c-89ed457b2c46 (view SPL)Mysoline (primidone, USP)prescriptionHuman PrescriptionValeant Pharmaceuticals North AmericaMANUFACTURE2013-08-275664900690, 664900691
15ba3794e3-4d34-41fd-9a66-e24549f17748 (view SPL)Primidone Tablets, USPprescriptionHuman PrescriptionGlobal PharmaceuticalsREPACK2010-09-285001151030, 001151031
16c7cb2073-9d44-4261-b308-02cd24c1f17a (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-02-199548681691, 548685067
17ccadc401-fbcd-45e5-9c76-c8307324f638 (view SPL)PRIMIDONE TABLETS, USP 50 MGprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-05-241425490680
18cce71bdb-1018-4f94-90d4-cf3cc804fbb3 (view SPL)PRIMIDONE TABLETS, USPAnticonvulsant Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-07-306006035371, 006035372
19dc19429e-ddaf-4092-8730-012a1d9f45e7 (view SPL)Primidone Tablets USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2011-02-045006152521
20e7a50a67-9653-463e-8c85-315b53f460c8 (view SPL)PRIMIDONE TABLETS, USPprescriptionHuman PrescriptionAvkare, Inc.2015-04-135422910509, 422910511

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