candesartan / Hydrochlorothiazide Oral Tablet

Brand(s)
Atacand HCT
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Lp (2015-03-19)
Oldest Current Product
2000-09-28
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\CANDESARTAN:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\CANDESARTAN CILEXETIL: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET\CANDESARTAN CILEXETIL: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\CANDESARTAN: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

candesartan cilexetil 16 mg / hydrochlorothiazide 12.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860162Atacand HCTNDAAstrazeneca Lp2000-09-28CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA02109348b021e4-5897-42fd-12be-3190a9b087e8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783001ANDAMylan Pharmaceuticals Inc.2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA090704f3c4f7ed-e667-4528-a675-b032c2a4425d
2333420131ANDAMacleods Pharmaceuticals Limited2015-03-07CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20410076630807-9717-44be-946d-756038cf677e
3498840662NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2012-12-05CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA0210936c875dc3-3cfe-4f84-a344-7e2a789568db
4605053758ANDAApotex Corp2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20288414622dfc-87a8-00cf-b150-c642fb67ce35

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684729Atacand HCTNDAPhysicians Total Care, Inc.2003-01-21CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLET001860162NDA0210938e50e65d-b79b-46b4-a147-796cb19f1407
2636295233ANDABryant Ranch Prepack2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLET605053758ANDA2028843854fc5d-3af8-4f77-b9dd-a8780a8d27e0

candesartan cilexetil 32 mg / hydrochlorothiazide 12.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860322Atacand HCTNDAAstrazeneca Lp2000-09-28CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA02109348b021e4-5897-42fd-12be-3190a9b087e8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783002ANDAMylan Pharmaceuticals Inc.2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA090704f3c4f7ed-e667-4528-a675-b032c2a4425d
2333420132ANDAMacleods Pharmaceuticals Limited2015-03-07CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20410076630807-9717-44be-946d-756038cf677e
3498840663NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2012-12-05CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA0210936c875dc3-3cfe-4f84-a344-7e2a789568db
4605053759ANDAApotex Corp2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20288414622dfc-87a8-00cf-b150-c642fb67ce35

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684869Atacand HCTNDAPhysicians Total Care, Inc.2003-11-13CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLET001860322NDA0210938e50e65d-b79b-46b4-a147-796cb19f1407
2636293377Atacand HCTNDABryant Ranch Prepack2000-09-28CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLET001860322NDA0210930ccca43b-b8d7-4310-b359-2e9dd4a681a9

candesartan cilexetil 32 mg / hydrochlorothiazide 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860324Atacand HCTNDAAstrazeneca Lp2008-09-02CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA02109348b021e4-5897-42fd-12be-3190a9b087e8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783003ANDAMylan Pharmaceuticals Inc.2012-12-04CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA090704f3c4f7ed-e667-4528-a675-b032c2a4425d
2333420133ANDAMacleods Pharmaceuticals Limited2015-03-07CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20410076630807-9717-44be-946d-756038cf677e
3498840664NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2012-12-05CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETNDA0210936c875dc3-3cfe-4f84-a344-7e2a789568db
4605053760ANDAApotex Corp2013-06-03CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDEORALTABLETANDA20288414622dfc-87a8-00cf-b150-c642fb67ce35

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA090704CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMYLAN LABORATORIES LTD2012-12-04ANDA090704_001, ANDA090704_002, ANDA090704_003
2ANDA202884CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEAPOTEX INC2012-12-04ANDA202884_001, ANDA202884_002, ANDA202884_003
3ANDA202965CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEDR REDDYS LABORATORIES LTD2013-06-03ANDA202965_001, ANDA202965_002, ANDA202965_003
4ANDA204100CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMACLEODS PHARMACEUTICALS LTD2015-02-27ANDA204100_001, ANDA204100_002, ANDA204100_003
5NDA021093ATACAND HCTASTRAZENECA PHARMACEUTICALS LP2000-09-05p5721263, TREATMENT OF HYPERTENSION, SUBSTANCENDA021093_001, NDA021093_002, NDA021093_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090704_001RXCANDESARTAN CILEXETIL (16MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-12-04CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
2ANDA090704_002RXHYDROCHLOROTHIAZIDE (12.5MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2012-12-04CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
3ANDA090704_003RXHYDROCHLOROTHIAZIDE (25MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2012-12-04CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
4ANDA202884_001RXCANDESARTAN CILEXETIL (16MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2012-12-04CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
5ANDA202884_002RXHYDROCHLOROTHIAZIDE (12.5MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2012-12-04CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
6ANDA202884_003RXCANDESARTAN CILEXETIL (32MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2013-06-03CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
7ANDA202965_001RXCANDESARTAN CILEXETIL (16MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2013-06-03CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
8ANDA202965_002RXHYDROCHLOROTHIAZIDE (12.5MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2013-06-03CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
9ANDA202965_003RXHYDROCHLOROTHIAZIDE (25MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2013-06-03CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
10ANDA204100_001RXCANDESARTAN CILEXETIL (16MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2015-02-27CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
11ANDA204100_002RXHYDROCHLOROTHIAZIDE (12.5MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2015-02-27CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
12ANDA204100_003RXCANDESARTAN CILEXETIL (32MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2015-02-27CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
13NDA021093_001RXCANDESARTAN CILEXETIL (16MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2000-09-05ATACAND HCT
14NDA021093_002RXHYDROCHLOROTHIAZIDE (12.5MG), CANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2000-09-05ATACAND HCT
15NDA021093_003RXCANDESARTAN CILEXETIL (32MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETTrueAB2008-05-16ATACAND HCT

patent(s)

#idexpiration dateapplication(s)
1p5721263 (view patent)2015-02-24NDA021093

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10ccca43b-b8d7-4310-b359-2e9dd4a681a9 (view SPL)ATACAND HCT 16-12.5 (candesartan cilexetilhydrochlorothiazide) TABLETS ATACAND HCT 32-12.5 (candesartan cilexetilhydrochlorothiazide) TABLETS ATACAND HCT 3225 candesartan cilexetil-hydrochlorothiazideprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636293377
214622dfc-87a8-00cf-b150-c642fb67ce35 (view SPL)CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS, 16 mg/12.5 mg, 32 mg/12.5 mg, 32 mg/25 mg.prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-03-123605053758, 605053759, 605053760
33854fc5d-3af8-4f77-b9dd-a8780a8d27e0 (view SPL)Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-151000636295233
448b021e4-5897-42fd-12be-3190a9b087e8 (view SPL)ATACAND HCT 16-12.5 (candesartan cilexetilhydrochlorothiazide) TABLETS ATACAND HCT 32-12.5 (candesartan cilexetilhydrochlorothiazide) TABLETS ATACAND HCT 3225 candesartan cilexetil-hydrochlorothiazideprescriptionHuman PrescriptionAstrazeneca Lp2015-03-1918001860162, 001860322, 001860324
56c875dc3-3cfe-4f84-a344-7e2a789568db (view SPL)Candesartan Cilexetil-Hydrochlorothiazide 16-12.5 Tablets Candesartan Cilexetil-Hydrochlorothiazide 32-12.5 Tablets Candesartan Cilexetil-Hydrochlorothiazide 3225 TabletsprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-12-165498840662, 498840663, 498840664
676630807-9717-44be-946d-756038cf677e (view SPL)Candesartan Cilexetil and Hydrochlorothiazide TabletsRx onlyprescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-03-071333420131, 333420132, 333420133
78e50e65d-b79b-46b4-a147-796cb19f1407 (view SPL)ATACAND HCT 16-12.5(candesartan cilexetilhydrochlorothiazide)TABLETSATACAND HCT 32-12.5(candesartan cilexetilhydrochlorothiazide)TABLETSATACAND HCT 3225candesartan cilexetil-hydrochlorothiazideprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-022548684729, 548684869
8f3c4f7ed-e667-4528-a675-b032c2a4425d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-318003783001, 003783002, 003783003

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