Amiodarone Oral Tablet

Brand(s)
Cordarone, Pacerone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. (2015-04-21)
Oldest Current Product
1985-12-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\AMIODARONE
FDAOB
ORAL\TABLET\AMIODARONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\AMIODARONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\AMIODARONE

product(s) by strength(s)

amiodarone hydrochloride 100 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450144PaceroneANDAUpsher-Smith Laboratories, Inc.2011-01-19AMIODARONE HYDROCHLORIDEORALTABLETANDA0751354c4ec9b0-13a5-49a8-b57b-b3f64e4316a7
2516724055ANDATaro Pharmaceuticals U.S.A., Inc.2001-03-30AMIODARONE HYDROCHLORIDEORALTABLETANDA0754247ccd3733-c3af-4a11-8500-0f99194c1472

amiodarone hydrochloride 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000084188CordaroneNDAWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.1985-12-01AMIODARONE HYDROCHLORIDEORALTABLETNDA01897251be39a2-9134-402c-95ad-defe47406ff8

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000939133ANDATeva Pharmaceuticals Usa Inc1998-11-30AMIODARONE HYDROCHLORIDEORALTABLETANDA0747390e70dd96-53ca-4bc3-ba70-0bd63dd94d5b
2001850144ANDAEon Labs, Inc.1998-12-23AMIODARONE HYDROCHLORIDEORALTABLETANDA075315108cd13a-b2d1-45a2-a654-650aa88155f4
3002450147PaceroneANDAUpsher-Smith Laboratories, Inc.2011-01-19AMIODARONE HYDROCHLORIDEORALTABLETANDA0751354c4ec9b0-13a5-49a8-b57b-b3f64e4316a7
4516724025ANDATaro Pharmaceuticals U.S.A., Inc.2001-03-30AMIODARONE HYDROCHLORIDEORALTABLETANDA0754247ccd3733-c3af-4a11-8500-0f99194c1472
5518620155ANDALibertas Pharma, Inc.2013-01-01AMIODARONE HYDROCHLORIDEORALTABLETANDA07706908641e51-abca-4c1c-ba19-d24435332018
6605052658ANDAApotex Corp2008-11-06AMIODARONE HYDROCHLORIDEORALTABLETANDA07857855876e4c-7e95-064a-8ca6-918eec85b043
7658410631ANDACadila Healthcare Limited2009-08-10AMIODARONE HYDROCHLORIDEORALTABLETANDA0790293e8db251-e3c5-4fba-be9a-6044a92f0beb
8683820227ANDAZydus Pharmaceuticals (Usa) Inc.2009-08-10AMIODARONE HYDROCHLORIDEORALTABLETANDA079029b41cbcb5-9c5d-4e45-a4f2-952df5f22c00

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154545ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1998-12-23AMIODARONE HYDROCHLORIDEORALTABLET001850144ANDA075315b96fab87-92ae-4439-89dd-799fd2754baf
2216950796ANDARebel Distributors Corp2009-08-10AMIODARONE HYDROCHLORIDEORALTABLET683820227ANDA079029e1a80191-fcb5-4aab-a972-accabe6ae9c7
3353560001ANDALake Erie Medical Dba Quality Care Products Llc1998-11-30AMIODARONE HYDROCHLORIDEORALTABLET000939133ANDA07473929e0670e-7bd0-418f-a47d-38190aaad733
4493490154ANDARemedyrepack Inc.2011-04-12AMIODARONE HYDROCHLORIDEORALTABLET683820227ANDA0790290d1482d3-4ff6-4e19-b062-57c10bd0d093
5510790906ANDAMylan Institutional Inc.1999-11-01AMIODARONE HYDROCHLORIDEORALTABLET000939133ANDA07473909a6638c-aefb-4112-b9e6-eae89ea7c247
6521250992ANDARemedyrepack Inc.2014-08-01AMIODARONE HYDROCHLORIDEORALTABLET000939133ANDA074739a7c77acb-1f37-437f-bf26-dcd8988324c7
7538081066ANDAState Of Florida Doh Central Pharmacy2014-11-01AMIODARONE HYDROCHLORIDEORALTABLET683820227ANDA079029d40060cd-e462-4952-866d-4e50fa13dce2
8548684618ANDAPhysicians Total Care, Inc.2002-04-22AMIODARONE HYDROCHLORIDEORALTABLET683820227ANDA07902957df7b65-7829-4364-894f-ae4c2772c733
9548685186PaceroneANDAPhysicians Total Care, Inc.2008-10-22AMIODARONE HYDROCHLORIDEORALTABLET002450147ANDA075135bac761ca-9467-49d9-b6fc-b57cd27ee5f7
10551544996ANDACardinal Health2009-09-25AMIODARONE HYDROCHLORIDEORALTABLET680840371ANDA079029e41319bc-517f-4b69-aa68-90d94ebfed4a
11551545492ANDACardinal Health1998-11-30AMIODARONE HYDROCHLORIDEORALTABLET510790906ANDA074739080d74e0-a5c0-49b6-83e4-4ee9e81c345f
12551545606PaceroneANDACardinal Health2011-01-19AMIODARONE HYDROCHLORIDEORALTABLET002450147ANDA075135a0f63765-a291-486c-b198-68a7f2414b83
13604290247ANDAGolden State Medical Supply, Inc.2001-03-30AMIODARONE HYDROCHLORIDEORALTABLET516724025ANDA0754247551b0a2-bfbd-4a9e-9348-654724c13a29
14617860309ANDARemedyrepack Inc.2015-05-15AMIODARONE HYDROCHLORIDEORALTABLET001850144ANDA075315618902d4-b4b0-4394-8022-163ed0dff424
15637390387ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2008-03-01AMIODARONE HYDROCHLORIDEORALTABLET001850144ANDA075315aeaa8449-e47e-4173-8f85-37c022fd170f
16650840456PaceroneANDARxpak Division Of Mckesson Corporation2014-04-28AMIODARONE HYDROCHLORIDEORALTABLET002450147ANDA075135a13a7632-74ea-4e2f-b791-190a4765c295
17675440570PaceroneANDAAphena Pharma Solutions - Tennessee, Inc.2011-01-19AMIODARONE HYDROCHLORIDEORALTABLET002450147ANDA0751352eceb4d5-0c47-49c3-8263-46f689388efe
18680840371ANDAAmerican Health Packaging2009-09-25AMIODARONE HYDROCHLORIDEORALTABLET683820227ANDA0790291aa2d919-37fc-4867-ae2d-f6be26528284
19762370108ANDAMckesson Contract Packaging2012-01-03AMIODARONE HYDROCHLORIDEORALTABLET001850144ANDA07531548f8c54d-0d7e-4469-86ca-93221d6c8f7d

amiodarone hydrochloride 300 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724056ANDATaro Pharmaceuticals U.S.A., Inc.2003-12-02AMIODARONE HYDROCHLORIDEORALTABLETANDA0763627ccd3733-c3af-4a11-8500-0f99194c1472

amiodarone hydrochloride 400 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450145PaceroneANDAUpsher-Smith Laboratories, Inc.2000-06-30AMIODARONE HYDROCHLORIDEORALTABLETANDA07531579cdc139-f39b-4617-b6e9-aea80dec3a3f
2516724057ANDATaro Pharmaceuticals U.S.A., Inc.2002-11-29AMIODARONE HYDROCHLORIDEORALTABLETANDA0763627ccd3733-c3af-4a11-8500-0f99194c1472
3518620156ANDALibertas Pharma, Inc.2013-01-01AMIODARONE HYDROCHLORIDEORALTABLETANDA07706908641e51-abca-4c1c-ba19-d24435332018

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074739AMIODARONE HYDROCHLORIDETEVA PHARMACEUTICALS USA1998-11-30ANDA074739_001
2ANDA074895AMIODARONE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1999-04-16ANDA074895_001
3ANDA075135PACERONEUPSHER SMITH LABORATORIES INC1998-04-30ANDA075135_001, ANDA075135_002
4ANDA075188AMIODARONE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1999-02-24ANDA075188_001
5ANDA075315AMIODARONE HYDROCHLORIDESANDOZ INC1998-12-23ANDA075315_001, ANDA075315_002
6ANDA075389AMIODARONE HYDROCHLORIDEBARR LABORATORIES INC2001-01-25ANDA075389_001
7ANDA075424AMIODARONE HYDROCHLORIDETARO PHARMACEUTICALS USA INC2001-03-30ANDA075424_001, ANDA075424_002
8ANDA076362AMIODARONE HYDROCHLORIDETARO PHARMACEUTICALS USA INC2002-11-29ANDA076362_001, ANDA076362_002
9ANDA077069AMIODARONE HYDROCHLORIDEMURTY PHARMACEUTICALS INC2005-04-08ANDA077069_001, ANDA077069_002
10ANDA078578AMIODARONE HYDROCHLORIDEAPOTEX CORP2008-11-06ANDA078578_001
11ANDA079029AMIODARONE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2008-09-16ANDA079029_001
12NDA018972CORDARONEWYETH PHARMACEUTICALS INC1985-12-24NDA018972_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074739_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB1998-11-30AMIODARONE HYDROCHLORIDE
2ANDA074895_001discontinuedAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalse1999-04-16AMIODARONE HYDROCHLORIDE
3ANDA075135_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB1998-04-30PACERONE
4ANDA075135_002RXAMIODARONE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2005-04-12PACERONE
5ANDA075188_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB1999-02-24AMIODARONE HYDROCHLORIDE
6ANDA075315_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB1998-12-23AMIODARONE HYDROCHLORIDE
7ANDA075315_002RXAMIODARONE HYDROCHLORIDE (400MG)ORALTABLETFalseAB2000-06-30AMIODARONE HYDROCHLORIDE
8ANDA075389_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2001-01-25AMIODARONE HYDROCHLORIDE
9ANDA075424_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2001-03-30AMIODARONE HYDROCHLORIDE
10ANDA075424_002RXAMIODARONE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2002-12-18AMIODARONE HYDROCHLORIDE
11ANDA076362_001RXAMIODARONE HYDROCHLORIDE (400MG)ORALTABLETFalseAB2002-11-29AMIODARONE HYDROCHLORIDE
12ANDA076362_002RXAMIODARONE HYDROCHLORIDE (300MG)ORALTABLETFalse2003-12-02AMIODARONE HYDROCHLORIDE
13ANDA077069_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2005-04-08AMIODARONE HYDROCHLORIDE
14ANDA077069_002RXAMIODARONE HYDROCHLORIDE (400MG)ORALTABLETFalseAB2005-04-08AMIODARONE HYDROCHLORIDE
15ANDA078578_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2008-11-06AMIODARONE HYDROCHLORIDE
16ANDA079029_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2008-09-16AMIODARONE HYDROCHLORIDE
17NDA018972_001RXAMIODARONE HYDROCHLORIDE (200MG)ORALTABLETTrueAB1985-12-24CORDARONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1080d74e0-a5c0-49b6-83e4-4ee9e81c345f (view SPL)AMIODARONE HYDROCHLORIDE TABLETS Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-056551545492
208641e51-abca-4c1c-ba19-d24435332018 (view SPL)AmiodaroneprescriptionHuman PrescriptionLibertas Pharma, Inc.MANUFACTURE, PACK2015-04-2310518620155, 518620156
309a6638c-aefb-4112-b9e6-eae89ea7c247 (view SPL)AMIODARONE HYDROCHLORIDE TABLETS Rx onlyprescriptionHuman PrescriptionMylan Institutional Inc.2015-07-034510790906
40d1482d3-4ff6-4e19-b062-57c10bd0d093 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-123493490154
50e70dd96-53ca-4bc3-ba70-0bd63dd94d5b (view SPL)AMIODARONE HYDROCHLORIDE TABLETS 9133 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-07-0614000939133
6108cd13a-b2d1-45a2-a654-650aa88155f4 (view SPL)Amiodarone Hydrochloride Tablets, 200 mgprescriptionHuman PrescriptionEon Labs, Inc.2015-04-2924001850144
71aa2d919-37fc-4867-ae2d-f6be26528284 (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-215680840371
829e0670e-7bd0-418f-a47d-38190aaad733 (view SPL)AMIODARONE HYDROCHLORIDE TABLETS 9133 Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-09-101353560001
92eceb4d5-0c47-49c3-8263-46f689388efe (view SPL)PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mgprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-05-093675440570
103e8db251-e3c5-4fba-be9a-6044a92f0beb (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-202658410631
1148f8c54d-0d7e-4469-86ca-93221d6c8f7d (view SPL)Amiodarone Hydrochloride Tablets, 200 mgprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-01-111762370108
124c4ec9b0-13a5-49a8-b57b-b3f64e4316a7 (view SPL)PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mgprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-11-1616002450144, 002450147
1351be39a2-9134-402c-95ad-defe47406ff8 (view SPL)Cordarone (amiodarone HCl) TABLETSprescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-04-2122000084188
1455876e4c-7e95-064a-8ca6-918eec85b043 (view SPL)AMIODARONE HYDROCHLORIDE TABLETS 200 mg Rx OnlyprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-07-166605052658
1557df7b65-7829-4364-894f-ae4c2772c733 (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-221548684618
16618902d4-b4b0-4394-8022-163ed0dff424 (view SPL)Amiodarone Hydrochloride Tablets, 200 mgprescriptionHuman PrescriptionRemedyrepack Inc.2015-05-151617860309
177551b0a2-bfbd-4a9e-9348-654724c13a29 (view SPL)Amiodarone HCl Tablets, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290247
1879cdc139-f39b-4617-b6e9-aea80dec3a3f (view SPL)PACERONE (Amiodarone Hydrochloride) Tablets, 400 mgprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.2015-06-1825002450145
197ccd3733-c3af-4a11-8500-0f99194c1472 (view SPL)Amiodarone HCl TabletsprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-189516724025, 516724055, 516724056, 516724057
20a0f63765-a291-486c-b198-68a7f2414b83 (view SPL)PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mgprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-032551545606
21a13a7632-74ea-4e2f-b791-190a4765c295 (view SPL)PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mgprescriptionHuman PrescriptionRxpak Division Of Mckesson CorporationREPACK2014-04-301650840456
22a7c77acb-1f37-437f-bf26-dcd8988324c7 (view SPL)AMIODARONE HYDROCHLORIDE TABLETS9133Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2014-08-011521250992
23aeaa8449-e47e-4173-8f85-37c022fd170f (view SPL)Amiodarone Hydrochloride Tablets, 200 mgprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-04-083637390387
24b41cbcb5-9c5d-4e45-a4f2-952df5f22c00 (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2015-04-067683820227
25b96fab87-92ae-4439-89dd-799fd2754baf (view SPL)Amiodarone Hydrochloride TabletprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-08-094006154545
26bac761ca-9467-49d9-b6fc-b57cd27ee5f7 (view SPL)PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-191548685186
27d40060cd-e462-4952-866d-4e50fa13dce2 (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-12-071538081066
28e1a80191-fcb5-4aab-a972-accabe6ae9c7 (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-04-131216950796
29e41319bc-517f-4b69-aa68-90d94ebfed4a (view SPL)Amiodarone Hydrochloride TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-172551544996

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