Propafenone Oral Tablet

Brand(s)
Rythmol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-03-03)
Oldest Current Product
2000-10-24
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PROPAFENONE
FDAOB
ORAL\TABLET\PROPAFENONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\PROPAFENONE HYDROCHLORIDE
ORAL\TABLET, FILM COATED\PROPAFENONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\PROPAFENONE
ORAL\TABLET, FILM COATED\PROPAFENONE

product(s) by strength(s)

propafenone hydrochloride 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730792RythmolNDAGlaxosmithkline Llc2010-01-04PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0191518dd938c8-d37c-4a82-b36d-dd0a2d31c8fa

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910582ANDAWatson Laboratories, Inc.2000-10-24PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075203a313c111-e539-47bc-9d57-c3767f74bcca
2006035448ANDAQualitest Pharmaceuticals2002-10-17PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075938d4a552ce-f215-4ec7-b5dd-aee266ba9b08
3534890551ANDAMutual Pharmaceutical Company, Inc.2001-11-29PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075998578d747f-c023-4d5a-9e9a-d4a970d8f69f
4625590230ANDAAnip Acquisition Company2015-03-31PROPAFENONE HYDROCHLORIDEORALTABLET, COATEDANDA0765508d1be333-be2b-4064-86a4-c2ad9ad07b83

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157574ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-10-17PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED006035448ANDA0759389017ff99-cf37-43f4-95cc-3477f1940c54
2510790996ANDAMylan Institutional Inc.2003-02-01PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED534890551ANDA07599836e02614-9346-483e-8beb-711519b80a9d
3548684770ANDAPhysicians Total Care, Inc.2005-05-18PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED534890551ANDA075998a7c8f090-c48c-44f7-9973-2cf4b491e35c
4551545095ANDACardinal Health2011-05-20PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED510790996ANDA0759989ad1b5f4-fbb7-46b5-a719-796d85cd4c54
5636293869ANDABryant Ranch Prepack2002-10-17PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED006035448ANDA07593812f36dbd-8b8e-47b6-a97f-4fe5cdd68245
6637390509ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2012-09-10PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED005910582ANDA075203cf103bcc-5b96-4699-be2c-d596d490a814
7680840361ANDAAmerican Health Packaging2012-05-01PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED005910582ANDA0752033b453b16-b050-4dda-8e2f-40924e7f7d1c

propafenone hydrochloride 225 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730794RythmolNDAGlaxosmithkline Llc2010-01-04PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0191518dd938c8-d37c-4a82-b36d-dd0a2d31c8fa

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910583ANDAWatson Laboratories, Inc.2000-10-24PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075203a313c111-e539-47bc-9d57-c3767f74bcca
2006035449ANDAQualitest Pharmaceuticals2002-10-17PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075938d4a552ce-f215-4ec7-b5dd-aee266ba9b08
3534890552ANDAMutual Pharmaceutical Company, Inc.2001-11-29PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075998578d747f-c023-4d5a-9e9a-d4a970d8f69f
4625590231ANDAAnip Acquisition Company2015-03-31PROPAFENONE HYDROCHLORIDEORALTABLET, COATEDANDA0765508d1be333-be2b-4064-86a4-c2ad9ad07b83

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685950ANDAPhysicians Total Care, Inc.2008-10-09PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED534890552ANDA075998a7c8f090-c48c-44f7-9973-2cf4b491e35c
2637390510ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2012-09-10PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATED005910583ANDA075203cf103bcc-5b96-4699-be2c-d596d490a814

propafenone hydrochloride 300 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006035450ANDAQualitest Pharmaceuticals2002-10-17PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075938d4a552ce-f215-4ec7-b5dd-aee266ba9b08
2534890553ANDAMutual Pharmaceutical Company, Inc.2001-11-29PROPAFENONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075998578d747f-c023-4d5a-9e9a-d4a970d8f69f
3625590232ANDAAnip Acquisition Company2015-03-31PROPAFENONE HYDROCHLORIDEORALTABLET, COATEDANDA0765508d1be333-be2b-4064-86a4-c2ad9ad07b83

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075203PROPAFENONE HYDROCHLORIDEWATSON LABORATORIES2000-10-24ANDA075203_001, ANDA075203_002
2ANDA075938PROPAFENONE HYDROCHLORIDEVINTAGE PHARMACEUTICALS INC2002-10-17ANDA075938_001, ANDA075938_002, ANDA075938_003
3ANDA075998PROPAFENONE HYDROCHLORIDEMUTUAL PHARMACEUTICAL CO INC2001-11-29ANDA075998_001, ANDA075998_002, ANDA075998_003
4ANDA076193PROPAFENONE HYDROCHLORIDETrueNESHER PHARMACEUTICALS USA LLC2002-02-07ANDA076193_001, ANDA076193_002, ANDA076193_003
5ANDA076550PROPAFENONE HYDROCHLORIDEANI PHARMACEUTICALS INC2004-04-23ANDA076550_001, ANDA076550_002, ANDA076550_003
6NDA019151RYTHMOLGLAXOSMITHKLINE LLC1989-11-27NDA019151_001, NDA019151_002, NDA019151_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075203_001RXPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2000-10-24PROPAFENONE HYDROCHLORIDE
2ANDA075203_002RXPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalseAB2000-10-24PROPAFENONE HYDROCHLORIDE
3ANDA075938_001RXPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2002-10-17PROPAFENONE HYDROCHLORIDE
4ANDA075938_002RXPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalseAB2002-10-17PROPAFENONE HYDROCHLORIDE
5ANDA075938_003RXPROPAFENONE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2002-10-17PROPAFENONE HYDROCHLORIDE
6ANDA075998_001RXPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2001-11-29PROPAFENONE HYDROCHLORIDE
7ANDA075998_002RXPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalseAB2001-11-29PROPAFENONE HYDROCHLORIDE
8ANDA075998_003RXPROPAFENONE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2001-11-29PROPAFENONE HYDROCHLORIDE
9ANDA076193_001discontinuedPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalse2002-02-07PROPAFENONE HYDROCHLORIDE
10ANDA076193_002discontinuedPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalse2002-02-07PROPAFENONE HYDROCHLORIDE
11ANDA076193_003discontinuedPROPAFENONE HYDROCHLORIDE (300MG)ORALTABLETFalse2002-02-07PROPAFENONE HYDROCHLORIDE
12ANDA076550_001RXPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2004-04-23PROPAFENONE HYDROCHLORIDE
13ANDA076550_002RXPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalseAB2004-04-23PROPAFENONE HYDROCHLORIDE
14ANDA076550_003RXPROPAFENONE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2004-04-23PROPAFENONE HYDROCHLORIDE
15NDA019151_001RXPROPAFENONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB1989-11-27RYTHMOL
16NDA019151_002RXPROPAFENONE HYDROCHLORIDE (300MG)ORALTABLETTrueAB1989-11-27RYTHMOL
17NDA019151_003RXPROPAFENONE HYDROCHLORIDE (225MG)ORALTABLETFalseAB1992-11-20RYTHMOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112f36dbd-8b8e-47b6-a97f-4fe5cdd68245 (view SPL)These highlights do not include all the information needed to use propafenone hydrochloride tablets safely and effectively. See full prescribing information for propafenone hydrochloride tablets. P ro p a f e n o n e Hydrochloride Tablets for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-04-281000636293869
236e02614-9346-483e-8beb-711519b80a9d (view SPL)PROPAFENONE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionMylan Institutional Inc.2013-01-042510790996
33b453b16-b050-4dda-8e2f-40924e7f7d1c (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use propafenone hydrochloride tablets safely and effectively. See full prescribing information for propafenone hydrochloride tablets.Propafenone hydrochloride tablets for oral useInitial U.S. Approval: 1989prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-02-112680840361
4578d747f-c023-4d5a-9e9a-d4a970d8f69f (view SPL)These highlights do not include all the information needed to use propafenone hydrochloride tablets safely and effectively. See full prescribing information for propafenone hydrochloride tablets. Propafenone Hydrochloride Tablets for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.MANUFACTURE2014-12-233534890551, 534890552, 534890553
58d1be333-be2b-4064-86a4-c2ad9ad07b83 (view SPL)These highlights do not include all the information needed to use Propafenone Hydrochloride Tablets safely and effectively. See full prescribing information for Propafenone Hydrochloride Tablets.Propafenone Hydrochloride Tablets for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, LABEL, MANUFACTURE, PACK2015-03-311625590230, 625590231, 625590232
68dd938c8-d37c-4a82-b36d-dd0a2d31c8fa (view SPL)These highlights do not include all the information needed to use RYTHMOL safely and effectively. See full prescribing information for RYTHMOL. RYTHMOL (propafenone hydrochloride) Tablets for oral useInitial U.S. Approval: 1989prescriptionHuman PrescriptionGlaxosmithkline Llc2014-03-0311001730792, 001730794
79017ff99-cf37-43f4-95cc-3477f1940c54 (view SPL)PROPAFENONE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-05-271006157574
89ad1b5f4-fbb7-46b5-a719-796d85cd4c54 (view SPL)PROPAFENONE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-122551545095
9a313c111-e539-47bc-9d57-c3767f74bcca (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use propafenone hydrochloride tablets safely and effectively. See full prescribing information for propafenone hydrochloride tablets. Propafenone hydrochloride tablets for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-07-1617005910582, 005910583
10a7c8f090-c48c-44f7-9973-2cf4b491e35c (view SPL)PROPAFENONE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-12-062548684770, 548685950
11cf103bcc-5b96-4699-be2c-d596d490a814 (view SPL)Propafenone HydrochlorideTabletsRx onlyprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2012-08-211637390509, 637390510
12d4a552ce-f215-4ec7-b5dd-aee266ba9b08 (view SPL)These highlights do not include all the information needed to use propafenone hydrochloride tablets safely and effectively. See full prescribing information for propafenone hydrochloride tablets. P ro p a f e n o n e Hydrochloride Tablets for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2013-06-067006035448, 006035449, 006035450

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