Perindopril Oral Tablet

Brand(s)
Aceon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Symplmed, Llc (2015-05-08)
Oldest Current Product
2009-11-10
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PERINDOPRIL
FDAOB
ORAL\TABLET\PERINDOPRIL ERBUMINE
SPL Active
ORAL\TABLET\PERINDOPRIL ERBUMINE
SPL Moiety
ORAL\TABLET\PERINDOPRIL
ORAL\TABLET\PERINDOPRIL: PERINDOPRILAT
ORAL\TABLET\PERINDOPRILAT

product(s) by strength(s)

perindopril erbumine 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618940000AceonNDASymplmed, Llc2014-10-10PERINDOPRIL ERBUMINEORALTABLETNDA020184340846a3-896e-40bf-a4d0-419922df71a1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540110ANDARoxane Laboratories, Inc2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA090072cbc5b3c3-4d2c-4fa0-adbb-8ddf42e881c5
2658620286ANDAAurobindo Pharma Limited2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA07907087768fbf-7c63-47da-8925-0316f343d6ef, d9033965-7cf5-41ef-9efa-d2eec745b43d
3681800235ANDALupin Pharmaceuticals, Inc.2010-03-15PERINDOPRIL ERBUMINEORALTABLETANDA078263fbb31482-9ac8-48c6-b814-5d467f22051b

perindopril erbumine 4 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101350599NDAMarlex Pharmaceuticals Inc2015-05-01PERINDOPRIL ERBUMINEORALTABLETNDA020184fcaefca9-e6ca-4c97-9eb8-7f1c619ce4d0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540111ANDARoxane Laboratories, Inc2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA090072cbc5b3c3-4d2c-4fa0-adbb-8ddf42e881c5
2658620287ANDAAurobindo Pharma Limited2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA07907087768fbf-7c63-47da-8925-0316f343d6ef, d9033965-7cf5-41ef-9efa-d2eec745b43d
3681800236ANDALupin Pharmaceuticals, Inc.2010-03-15PERINDOPRIL ERBUMINEORALTABLETANDA078263fbb31482-9ac8-48c6-b814-5d467f22051b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1005271919NDALannett Company, Inc.2014-10-01PERINDOPRIL ERBUMINEORALTABLET618940001NDA020184f0492050-a966-41be-80b5-a58da7ba2bcf

perindopril erbumine 8 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101350600NDAMarlex Pharmaceuticals Inc2015-05-01PERINDOPRIL ERBUMINEORALTABLETNDA020184fcaefca9-e6ca-4c97-9eb8-7f1c619ce4d0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540112ANDARoxane Laboratories, Inc2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA090072cbc5b3c3-4d2c-4fa0-adbb-8ddf42e881c5
2658620288ANDAAurobindo Pharma Limited2009-11-10PERINDOPRIL ERBUMINEORALTABLETANDA07907087768fbf-7c63-47da-8925-0316f343d6ef, d9033965-7cf5-41ef-9efa-d2eec745b43d
3681800237ANDALupin Pharmaceuticals, Inc.2010-03-15PERINDOPRIL ERBUMINEORALTABLETANDA078263fbb31482-9ac8-48c6-b814-5d467f22051b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1005271920NDALannett Company, Inc.2014-10-01PERINDOPRIL ERBUMINEORALTABLET618940002NDA020184f0492050-a966-41be-80b5-a58da7ba2bcf

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078138PERINDOPRIL ERBUMINEANI PHARMACEUTICALS INC2009-11-10ANDA078138_001, ANDA078138_002, ANDA078138_003
2ANDA078263PERINDOPRIL ERBUMINELUPIN LTD2010-01-27ANDA078263_001, ANDA078263_002, ANDA078263_003
3ANDA079070PERINDOPRIL ERBUMINEAUROBINDO PHARMA LTD2009-11-10ANDA079070_001, ANDA079070_002, ANDA079070_003
4ANDA090072PERINDOPRIL ERBUMINEROXANE LABORATORIES INC2009-11-10ANDA090072_001, ANDA090072_002, ANDA090072_003
5ANDA090463PERINDOPRIL ERBUMINEAPOTEX INC2010-08-30ANDA090463_001, ANDA090463_002, ANDA090463_003
6NDA020184ACEONSYMPLMED PHARMACEUTICALS LLC1993-12-30NDA020184_001, NDA020184_002, NDA020184_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078138_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
2ANDA078138_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
3ANDA078138_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
4ANDA078263_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB2010-01-27PERINDOPRIL ERBUMINE
5ANDA078263_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB2010-01-27PERINDOPRIL ERBUMINE
6ANDA078263_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETFalseAB2010-01-27PERINDOPRIL ERBUMINE
7ANDA079070_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
8ANDA079070_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
9ANDA079070_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
10ANDA090072_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
11ANDA090072_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
12ANDA090072_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETFalseAB2009-11-10PERINDOPRIL ERBUMINE
13ANDA090463_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB2010-08-30PERINDOPRIL ERBUMINE
14ANDA090463_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB2010-08-30PERINDOPRIL ERBUMINE
15ANDA090463_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETFalseAB2010-08-30PERINDOPRIL ERBUMINE
16NDA020184_001RXPERINDOPRIL ERBUMINE (2MG)ORALTABLETFalseAB1993-12-30ACEON
17NDA020184_002RXPERINDOPRIL ERBUMINE (4MG)ORALTABLETFalseAB1993-12-30ACEON
18NDA020184_003RXPERINDOPRIL ERBUMINE (8MG)ORALTABLETTrueAB1993-12-30ACEON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1340846a3-896e-40bf-a4d0-419922df71a1 (view SPL)These highlights do not include all the information needed to use ACEON safely and effectively. See full prescribing information for ACEON. ACEON (perindopril erbumine) 2, 4 and 8mg Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionSymplmed, LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-05-084618940000, 618940001, 618940002
287768fbf-7c63-47da-8925-0316f343d6ef (view SPL)These highlights do not include all the information needed to use PERINDOPRIL ERBUMINE TABLETS safely and effectively. See full prescribing information for PERINDOPRIL ERBUMINE TABLETS. PERINDOPRIL ERBUMINE Tablets, for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-04-098658620286, 658620287, 658620288
397a9e8bf-91ed-4256-97d4-f9504bb01373 (view SPL)These highlights do not include all the information needed to use ACEON safely and effectively. See full prescribing information for ACEON. ACEON (perindopril erbumine) 2, 4 and 8mg Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionXoma (Us) Llcanalysis, api manufacture, label, manufacture, pack2013-03-113762340000
4cbc5b3c3-4d2c-4fa0-adbb-8ddf42e881c5 (view SPL)These highlights do not include all the information needed to use PERINDOPRIL erbumine tablets safely and effectively. See full prescribing information for PERINDOPRIL erbumine tablets. PERINDOPRIL erbumine tablets 2 mg, 4 mg and 8 mg, for oral use Initial U.S. Approval: 1993prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-04-305000540110, 000540111, 000540112
5d9033965-7cf5-41ef-9efa-d2eec745b43d (view SPL)prescriptionHuman PrescriptionAurobindo Pharma LimitedMANUFACTURE2009-11-111658620286, 658620287, 658620288
6f0492050-a966-41be-80b5-a58da7ba2bcf (view SPL)These highlights do not include all the information needed to use Perindopril Erbumine Tablets safely and effectively. See full prescribing information for Perindopril Erbumine Tablets. Perindopril Erbumine 4 and 8 mg Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-033005271919, 005271920
7fbb31482-9ac8-48c6-b814-5d467f22051b (view SPL)Perindopril Erbumine Tablets 2 mg, 4 mg and 8 mgprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.MANUFACTURE2010-01-011681800235, 681800236, 681800237
8fcaefca9-e6ca-4c97-9eb8-7f1c619ce4d0 (view SPL)These highlights do not include all the information needed to use Perindopril Erbumine Tablets safely and effectively. See full prescribing information for Perindopril Erbumine Tablets. Perindopril Erbumine 4 and 8 mg Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-05-281101350599, 101350600

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