Dipyridamole Oral Tablet

Brand(s)
Persantine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2011-12-01)
Oldest Current Product
1980-10-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\DIPYRIDAMOLE
FDAOB
ORAL\TABLET\DIPYRIDAMOLE
SPL Active
ORAL\TABLET, COATED\DIPYRIDAMOLE
ORAL\TABLET, FILM COATED\DIPYRIDAMOLE
ORAL\TABLET\DIPYRIDAMOLE
SPL Moiety
ORAL\TABLET, COATED\DIPYRIDAMOLE
ORAL\TABLET, FILM COATED\DIPYRIDAMOLE
ORAL\TABLET\DIPYRIDAMOLE

product(s) by strength(s)

dipyridamole 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970017PersantineNDABoehringer Ingelheim Pharmaceuticals, Inc.1999-06-01DIPYRIDAMOLEORALTABLET, COATEDNDA012836ca68879c-0214-4d7c-93b0-bdaf8ef23f8e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540434NDA AUTHORIZED GENERICRoxane Laboratories, Inc2012-02-15DIPYRIDAMOLEORALTABLETNDA012836ae7585ec-1280-40fe-b888-613b8a0e6ef6
2001151070ANDAGlobal Pharmaceuticals2007-07-18DIPYRIDAMOLEORALTABLETANDA040782a18b2af5-7c4a-4b7f-92c7-8a76e34da373
3005271461ANDALannett Company, Inc.2008-04-23DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0408981b82871b-f60b-4485-9a45-026aeb18b484
4005550252ANDABarr Laboratories Inc.1980-10-01DIPYRIDAMOLEORALTABLET, FILM COATEDANDA087184cc41deca-c10f-437d-b639-e5875712f168
5502680263ANDAAvpak2007-08-05DIPYRIDAMOLEORALTABLET, FILM COATEDANDA04078293ba8d29-1ac7-fe80-b571-f8c6617c1d49
6649800133ANDARising Pharmaceuticals, Inc.2007-08-05DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0407330146650f-d6e6-4a9c-8925-415b3c92b0e7
7658410662ANDACadila Healthcare Limited2008-05-22DIPYRIDAMOLEORALTABLET, FILM COATEDANDA040874312aadb1-435c-4aa7-8e46-6506cedacaa0
8683820187ANDAZydus Pharmaceuticals (Usa) Inc.2008-05-22DIPYRIDAMOLEORALTABLET, FILM COATEDANDA040874004bada0-dbf7-4a94-8792-6833d7eeda2b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009041086ANDAMajor2008-10-30DIPYRIDAMOLEORALTABLET, FILM COATED649800133ANDA0407335dab2bdc-8e4c-450a-8a57-7581584e8bd8
2422910526ANDAAvkare, Inc.2007-07-08DIPYRIDAMOLEORALTABLET, FILM COATED001151070ANDA040782bb13afb5-d582-40bd-a266-71f2b99e6797

dipyridamole 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970018PersantineNDABoehringer Ingelheim Pharmaceuticals, Inc.1999-06-01DIPYRIDAMOLEORALTABLET, COATEDNDA012836ca68879c-0214-4d7c-93b0-bdaf8ef23f8e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540435NDA AUTHORIZED GENERICRoxane Laboratories, Inc2012-02-15DIPYRIDAMOLEORALTABLETNDA012836ae7585ec-1280-40fe-b888-613b8a0e6ef6
2001151071ANDAGlobal Pharmaceuticals2007-07-18DIPYRIDAMOLEORALTABLETANDA040782a18b2af5-7c4a-4b7f-92c7-8a76e34da373
3005271462ANDALannett Company, Inc.2008-04-23DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0408981b82871b-f60b-4485-9a45-026aeb18b484
4005550285ANDABarr Laboratories Inc.1982-01-01DIPYRIDAMOLEORALTABLET, FILM COATEDANDA087716cc41deca-c10f-437d-b639-e5875712f168
5502680264ANDAAvpak2011-08-05DIPYRIDAMOLEORALTABLET, FILM COATEDANDA04078293ba8d29-1ac7-fe80-b571-f8c6617c1d49
6649800134ANDARising Pharmaceuticals, Inc.2007-02-13DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0407330146650f-d6e6-4a9c-8925-415b3c92b0e7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151573ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-01-23DIPYRIDAMOLEORALTABLET, FILM COATED005550285ANDA087716dcf785b2-e923-43bf-93bb-00a9501479f4
2009041087ANDAMajor2008-10-30DIPYRIDAMOLEORALTABLET, FILM COATED649800134ANDA0407335dab2bdc-8e4c-450a-8a57-7581584e8bd8
3422910527ANDAAvkare, Inc.2007-07-08DIPYRIDAMOLEORALTABLET, FILM COATED001151071ANDA040782bb13afb5-d582-40bd-a266-71f2b99e6797
4551543387ANDACardinal Health2008-10-30DIPYRIDAMOLEORALTABLET, FILM COATED009041087ANDA040733a892a51b-d66c-4b17-be80-9df56f401ea1
5551544325ANDACardinal Health2011-08-05DIPYRIDAMOLEORALTABLET, FILM COATED502680264ANDA04078216d4ec47-fbfe-4c18-b0fe-d4def625b4c3

dipyridamole 75 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970019PersantineNDABoehringer Ingelheim Pharmaceuticals, Inc.1999-06-01DIPYRIDAMOLEORALTABLET, COATEDNDA012836ca68879c-0214-4d7c-93b0-bdaf8ef23f8e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540436NDA AUTHORIZED GENERICRoxane Laboratories, Inc2012-02-15DIPYRIDAMOLEORALTABLETNDA012836ae7585ec-1280-40fe-b888-613b8a0e6ef6
2001151072ANDAGlobal Pharmaceuticals2007-07-18DIPYRIDAMOLEORALTABLETANDA040782a18b2af5-7c4a-4b7f-92c7-8a76e34da373
3005271463ANDALannett Company, Inc.2008-04-23DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0408981b82871b-f60b-4485-9a45-026aeb18b484
4005550286ANDABarr Laboratories Inc.1982-01-01DIPYRIDAMOLEORALTABLET, FILM COATEDANDA087717cc41deca-c10f-437d-b639-e5875712f168
5502680265ANDAAvpak2011-08-05DIPYRIDAMOLEORALTABLET, FILM COATEDANDA04078293ba8d29-1ac7-fe80-b571-f8c6617c1d49
6649800135ANDARising Pharmaceuticals, Inc.2007-02-13DIPYRIDAMOLEORALTABLET, FILM COATEDANDA0407330146650f-d6e6-4a9c-8925-415b3c92b0e7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009041088ANDAMajor2008-10-30DIPYRIDAMOLEORALTABLET, FILM COATED649800135ANDA0407335dab2bdc-8e4c-450a-8a57-7581584e8bd8
2422910528ANDAAvkare, Inc.2007-07-08DIPYRIDAMOLEORALTABLET, FILM COATED001151072ANDA040782bb13afb5-d582-40bd-a266-71f2b99e6797
3551541337ANDACardinal Health2008-10-30DIPYRIDAMOLEORALTABLET, FILM COATED009041088ANDA040733a892a51b-d66c-4b17-be80-9df56f401ea1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040542DIPYRIDAMOLETruePROSAM LABS LLC2006-04-21ANDA040542_001, ANDA040542_002, ANDA040542_003
2ANDA040733DIPYRIDAMOLEMURTY PHARMACEUTICALS INC2007-02-13ANDA040733_001, ANDA040733_002, ANDA040733_003
3ANDA040782DIPYRIDAMOLEIMPAX LABORATORIES INC2007-07-18ANDA040782_001, ANDA040782_002, ANDA040782_003
4ANDA040874DIPYRIDAMOLEZYDUS PHARMACEUTICALS USA INC2008-01-28ANDA040874_001, ANDA040874_002, ANDA040874_003
5ANDA040898DIPYRIDAMOLELANNETT HOLDINGS INC2008-04-23ANDA040898_001, ANDA040898_002, ANDA040898_003
6ANDA086944DIPYRIDAMOLETrueSANDOZ INC1991-04-16ANDA086944_002
7ANDA087160DIPYRIDAMOLETrueWATSON LABORATORIES INC1996-06-07ANDA087160_001
8ANDA087184DIPYRIDAMOLEBARR LABORATORIES INC1990-10-03ANDA087184_001
9ANDA087561DIPYRIDAMOLETrueSANDOZ INC1992-02-25ANDA087561_001
10ANDA087562DIPYRIDAMOLETrueSANDOZ INC1992-02-25ANDA087562_001
11ANDA087716DIPYRIDAMOLEBARR LABORATORIES INC1990-10-03ANDA087716_001
12ANDA087717DIPYRIDAMOLEBARR LABORATORIES INC1990-10-03ANDA087717_001
13ANDA088999DIPYRIDAMOLETrueGLENMARK GENERICS INC USA1991-02-05ANDA088999_001
14ANDA089000DIPYRIDAMOLETrueGLENMARK GENERICS INC USA1991-02-05ANDA089000_001
15ANDA089001DIPYRIDAMOLETrueGLENMARK GENERICS INC USA1991-02-05ANDA089001_001
16ANDA089425DIPYRIDAMOLEPUREPAC PHARMACEUTICAL CO1990-07-12ANDA089425_001
17ANDA089426DIPYRIDAMOLETruePUREPAC PHARMACEUTICAL CO1990-07-12ANDA089426_001
18ANDA089427DIPYRIDAMOLETruePUREPAC PHARMACEUTICAL CO1990-07-12ANDA089427_001
19NDA012836PERSANTINEBOEHRINGER INGELHEIM PHARMACEUTICALS INC1986-12-22NDA012836_003, NDA012836_004, NDA012836_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040542_001discontinuedDIPYRIDAMOLE (25MG)ORALTABLETFalse2006-04-21DIPYRIDAMOLE
2ANDA040542_002discontinuedDIPYRIDAMOLE (50MG)ORALTABLETFalse2006-04-21DIPYRIDAMOLE
3ANDA040542_003discontinuedDIPYRIDAMOLE (75MG)ORALTABLETFalse2006-04-21DIPYRIDAMOLE
4ANDA040733_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB2007-02-13DIPYRIDAMOLE
5ANDA040733_002RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB2007-02-13DIPYRIDAMOLE
6ANDA040733_003RXDIPYRIDAMOLE (75MG)ORALTABLETFalseAB2007-02-13DIPYRIDAMOLE
7ANDA040782_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB2007-07-18DIPYRIDAMOLE
8ANDA040782_002RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB2007-07-18DIPYRIDAMOLE
9ANDA040782_003RXDIPYRIDAMOLE (75MG)ORALTABLETFalseAB2007-07-18DIPYRIDAMOLE
10ANDA040874_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB2008-01-28DIPYRIDAMOLE
11ANDA040874_002RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB2008-01-28DIPYRIDAMOLE
12ANDA040874_003RXDIPYRIDAMOLE (75MG)ORALTABLETFalseAB2008-01-28DIPYRIDAMOLE
13ANDA040898_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB2008-04-23DIPYRIDAMOLE
14ANDA040898_002RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB2008-04-23DIPYRIDAMOLE
15ANDA040898_003RXDIPYRIDAMOLE (75MG)ORALTABLETFalseAB2008-04-23DIPYRIDAMOLE
16ANDA086944_002discontinuedDIPYRIDAMOLE (25MG)ORALTABLETFalse1991-04-16DIPYRIDAMOLE
17ANDA087160_001discontinuedDIPYRIDAMOLE (50MG)ORALTABLETFalse1996-06-07DIPYRIDAMOLE
18ANDA087184_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB1990-10-03DIPYRIDAMOLE
19ANDA087561_001discontinuedDIPYRIDAMOLE (75MG)ORALTABLETFalse1992-02-25DIPYRIDAMOLE
20ANDA087562_001discontinuedDIPYRIDAMOLE (50MG)ORALTABLETFalse1992-02-25DIPYRIDAMOLE
21ANDA087716_001RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB1990-10-03DIPYRIDAMOLE
22ANDA087717_001RXDIPYRIDAMOLE (75MG)ORALTABLETFalseAB1990-10-03DIPYRIDAMOLE
23ANDA088999_001discontinuedDIPYRIDAMOLE (25MG)ORALTABLETFalse1991-02-05DIPYRIDAMOLE
24ANDA089000_001discontinuedDIPYRIDAMOLE (50MG)ORALTABLETFalse1991-02-05DIPYRIDAMOLE
25ANDA089001_001discontinuedDIPYRIDAMOLE (75MG)ORALTABLETFalse1991-02-05DIPYRIDAMOLE
26ANDA089425_001RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB1990-07-12DIPYRIDAMOLE
27ANDA089426_001discontinuedDIPYRIDAMOLE (50MG)ORALTABLETFalse1990-07-12DIPYRIDAMOLE
28ANDA089427_001discontinuedDIPYRIDAMOLE (75MG)ORALTABLETFalse1990-07-12DIPYRIDAMOLE
29NDA012836_003RXDIPYRIDAMOLE (25MG)ORALTABLETFalseAB1986-12-22PERSANTINE
30NDA012836_004RXDIPYRIDAMOLE (50MG)ORALTABLETFalseAB1987-02-06PERSANTINE
31NDA012836_005RXDIPYRIDAMOLE (75MG)ORALTABLETTrueAB1987-02-06PERSANTINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1004bada0-dbf7-4a94-8792-6833d7eeda2b (view SPL)Dipyridamole Tablets, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2011-04-292683820187
20146650f-d6e6-4a9c-8925-415b3c92b0e7 (view SPL)Dipyridamole Tablets, USP 25 mg, 50 mg, and 75 mg tabletsprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2012-08-133649800133, 649800134, 649800135
316d4ec47-fbfe-4c18-b0fe-d4def625b4c3 (view SPL)DIPYRIDAMOLE TABLETS USP25 MG, 50 MG AND 75 MGprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-171551544325
41b82871b-f60b-4485-9a45-026aeb18b484 (view SPL)DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mgprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-244005271461, 005271462, 005271463
5312aadb1-435c-4aa7-8e46-6506cedacaa0 (view SPL)Dipyridamole Tablets, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-292658410662
65dab2bdc-8e4c-450a-8a57-7581584e8bd8 (view SPL)Dipyridamole USP25 mg, 50 mg, and 75 mg tabletsprescriptionHuman PrescriptionMajor2012-08-204009041086, 009041087, 009041088
793ba8d29-1ac7-fe80-b571-f8c6617c1d49 (view SPL)DIPYRIDAMOLE TABLETS USP25 MG, 50 MG AND 75 MGprescriptionHuman PrescriptionAvpak2014-09-115502680263, 502680264, 502680265
8a18b2af5-7c4a-4b7f-92c7-8a76e34da373 (view SPL)DIPYRIDAMOLE TABLETS USP 25 MG, 50 MG AND 75 MGprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2013-11-123001151070, 001151071, 001151072
9a892a51b-d66c-4b17-be80-9df56f401ea1 (view SPL)Dipyridamole USP25 mg, 50 mg, and 75 mg tabletsprescriptionHuman PrescriptionCardinal HealthREPACK2013-07-222551541337, 551543387
10ae7585ec-1280-40fe-b888-613b8a0e6ef6 (view SPL)DIPYRIDAMOLE Tablets USPprescriptionHuman PrescriptionRoxane Laboratories, IncANALYSIS, API MANUFACTURE, MANUFACTURE2012-02-151000540434, 000540435, 000540436
11bb13afb5-d582-40bd-a266-71f2b99e6797 (view SPL)DIPYRIDAMOLE TABLETS USP25 MG, 50 MG AND 75 MGprescriptionHuman PrescriptionAvkare, Inc.2009-03-032422910526, 422910527, 422910528
12ca68879c-0214-4d7c-93b0-bdaf8ef23f8e (view SPL)Persantine(dipyridamole USP)25 mg, 50 mg, and 75 mg tabletsprescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2011-12-014005970017, 005970018, 005970019
13cc41deca-c10f-437d-b639-e5875712f168 (view SPL)DIPYRIDAMOLE TABLETS, USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-10-116005550252, 005550285, 005550286
14dcf785b2-e923-43bf-93bb-00a9501479f4 (view SPL)DIPYRIDAMOLE TABLETS, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-09-173006151573

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