Indapamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2010-01-14)
Oldest Current Product
1996-03-28
License(s)
ANDA
RxNORM
ORAL TABLET\INDAPAMIDE
FDAOB
ORAL\TABLET\INDAPAMIDE
SPL Active
ORAL\TABLET, FILM COATED\INDAPAMIDE
ORAL\TABLET\INDAPAMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\INDAPAMIDE
ORAL\TABLET\INDAPAMIDE

product(s) by strength(s)

indapamide 1.25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282597ANDAActavis Elizabeth Llc2007-01-02INDAPAMIDEORALTABLET, FILM COATEDANDA074722a8a4ec2c-9d4b-482b-ad29-88185c96db74
2003780069ANDAMylan Pharmaceuticals Inc.1997-03-26INDAPAMIDEORALTABLET, FILM COATEDANDA0744615c098a1b-cca0-4c27-8e0e-3a27cb2fc003

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950576ANDARebel Distributors Corp2010-01-18INDAPAMIDEORALTABLET, FILM COATED003780069ANDA07446192c7be7d-8c89-476a-b131-9deef76ed016
2353560226ANDALake Erie Medical Dba Quality Care Products Llc2011-07-12INDAPAMIDEORALTABLET, FILM COATED003780069ANDA074461de43a844-ad67-41d0-bb9b-935d925e3b3d
3681511294ANDACarilion Materials Management1997-03-26INDAPAMIDEORALTABLET, FILM COATED003780069ANDA07446155cf66a2-286d-44d8-8887-17a80939a66f

indapamide 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282571ANDAActavis Elizabeth Llc2007-01-02INDAPAMIDEORALTABLET, FILM COATEDANDA074722a8a4ec2c-9d4b-482b-ad29-88185c96db74
2003780080ANDAMylan Pharmaceuticals Inc.1996-03-28INDAPAMIDEORALTABLET, FILM COATEDANDA0744615c098a1b-cca0-4c27-8e0e-3a27cb2fc003

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490015ANDARemedyrepack Inc.2010-09-16INDAPAMIDEORALTABLET003780080ANDA0744614633eab3-2c9e-4a5f-a282-108445b7cea7
2510790868ANDAMylan Institutional Inc.1996-05-01INDAPAMIDEORALTABLET, FILM COATED003780080ANDA0744619c381e1d-001b-4db0-b907-2933e9243345
3636295216ANDABryant Ranch Prepack2007-01-02INDAPAMIDEORALTABLET, FILM COATED002282571ANDA0747221c85221a-6604-47b9-925c-b5a6e7e74883

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074299INDAPAMIDEANI PHARMACEUTICALS INC1995-07-27ANDA074299_001, ANDA074299_002
2ANDA074461INDAPAMIDEMYLAN PHARMACEUTICALS INC1996-03-27ANDA074461_001, ANDA074461_002
3ANDA074498INDAPAMIDETrueANI PHARMACEUTICALS INC1996-10-31ANDA074498_001, ANDA074498_002
4ANDA074585INDAPAMIDETrueWATSON LABORATORIES INC1996-09-26ANDA074585_001, ANDA074585_002
5ANDA074594INDAPAMIDETrueSANDOZ INC1996-05-23ANDA074594_001, ANDA074594_002
6ANDA074665INDAPAMIDETrueTEVA PHARMACEUTICALS USA INC1997-04-04ANDA074665_001, ANDA074665_002
7ANDA074722INDAPAMIDEACTAVIS ELIZABETH LLC1996-06-17ANDA074722_001, ANDA074722_002
8ANDA075105INDAPAMIDEMYLAN PHARMACEUTICALS INC1998-07-23ANDA075105_001, ANDA075105_002
9ANDA075201INDAPAMIDETrueAMERIGEN PHARMACEUTICALS LTD1998-12-04ANDA075201_001, ANDA075201_002
10NDA018538LOZOLTrueSANOFI AVENTIS US LLC1983-07-06NDA018538_001, NDA018538_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074299_001RXINDAPAMIDE (2.5MG)ORALTABLETFalseAB1995-07-27INDAPAMIDE
2ANDA074299_002RXINDAPAMIDE (1.25MG)ORALTABLETFalseAB1996-04-29INDAPAMIDE
3ANDA074461_001RXINDAPAMIDE (2.5MG)ORALTABLETTrueAB1996-03-27INDAPAMIDE
4ANDA074461_002RXINDAPAMIDE (1.25MG)ORALTABLETFalseAB1997-03-26INDAPAMIDE
5ANDA074498_001discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1996-10-31INDAPAMIDE
6ANDA074498_002discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1998-02-12INDAPAMIDE
7ANDA074585_001discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1996-09-26INDAPAMIDE
8ANDA074585_002discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1996-09-26INDAPAMIDE
9ANDA074594_001discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1996-05-23INDAPAMIDE
10ANDA074594_002discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1996-05-23INDAPAMIDE
11ANDA074665_001discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1997-04-04INDAPAMIDE
12ANDA074665_002discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1997-04-04INDAPAMIDE
13ANDA074722_001RXINDAPAMIDE (1.25MG)ORALTABLETFalseAB1996-06-17INDAPAMIDE
14ANDA074722_002RXINDAPAMIDE (2.5MG)ORALTABLETFalseAB1996-06-17INDAPAMIDE
15ANDA075105_001RXINDAPAMIDE (1.25MG)ORALTABLETFalseAB1998-07-23INDAPAMIDE
16ANDA075105_002RXINDAPAMIDE (2.5MG)ORALTABLETFalseAB1998-07-23INDAPAMIDE
17ANDA075201_001discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1998-12-04INDAPAMIDE
18ANDA075201_002discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1998-12-04INDAPAMIDE
19NDA018538_001discontinuedINDAPAMIDE (2.5MG)ORALTABLETFalse1983-07-06LOZOL
20NDA018538_002discontinuedINDAPAMIDE (1.25MG)ORALTABLETFalse1993-04-29LOZOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11c85221a-6604-47b9-925c-b5a6e7e74883 (view SPL)INDAPAMIDE TABLETS, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081000636295216
24633eab3-2c9e-4a5f-a282-108445b7cea7 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-09-1628493490015
355cf66a2-286d-44d8-8887-17a80939a66f (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-01-142681511294
45c098a1b-cca0-4c27-8e0e-3a27cb2fc003 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-01-144003780069, 003780080
592c7be7d-8c89-476a-b131-9deef76ed016 (view SPL)IndapamideprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-291216950576
69c381e1d-001b-4db0-b907-2933e9243345 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-10-042510790868
7a8a4ec2c-9d4b-482b-ad29-88185c96db74 (view SPL)INDAPAMIDE TABLETS, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE2013-07-168002282571, 002282597
8de43a844-ad67-41d0-bb9b-935d925e3b3d (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcANALYSIS, MANUFACTURE, relabel2011-07-123043353560226

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