Atenolol / Chlorthalidone Oral Tablet

Brand(s)
Tenoretic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2012-10-31)
Oldest Current Product
1990-09-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ATENOLOL:CHLORTHALIDONE
FDAOB
ORAL\TABLET\ATENOLOL: CHLORTHALIDONE
SPL Active
ORAL\TABLET\ATENOLOL: CHLORTHALIDONE
SPL Moiety
ORAL\TABLET\ATENOLOL: CHLORTHALIDONE

product(s) by strength(s)

atenolol 100 mg / chlorthalidone 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100117TenoreticNDAAstrazeneca Pharmaceuticals Lp1990-09-01ATENOLOL, CHLORTHALIDONEORALTABLETNDA0187600ebcca1e-ca16-4483-429a-aec5dcacd1dc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782064ANDAMylan Pharmaceuticals Inc.2013-03-28ATENOLOL, CHLORTHALIDONEORALTABLETANDA07420399ae0271-47d8-4321-96e0-55124811df1a
2005915783ANDAWatson Laboratories, Inc.1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLETANDA073665a6794dfa-adbb-491b-9d48-f89a44e866c5
3534890532ANDAMutual Pharmaceutical Company, Inc.1993-04-29ATENOLOL, CHLORTHALIDONEORALTABLETANDA073582b4cfa459-c1c3-4fe2-ac2d-afeea2b96cca

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950744ANDARebel Distributors Corp1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915783ANDA073665cd4f6a14-a2eb-4157-83a7-91ab4e9926e5
2353560859ANDALake Erie Medical Dba Quality Care Products Llc2013-03-28ATENOLOL, CHLORTHALIDONEORALTABLET003782064ANDA0742031203ed3a-7a1f-4598-818e-7c2e7a6d1ce7
3548683064ANDAPhysicians Total Care, Inc.2005-05-05ATENOLOL, CHLORTHALIDONEORALTABLET00591578301ANDA07366584e9de8f-27c3-4177-827a-6992495511ac
4636293738ANDABryant Ranch Prepack1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915783ANDA0736651c3c2cbf-e307-4327-a044-69451aef66ae
5687889041ANDAPreferred Pharmaceuticals, Inc.1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915783ANDA0736651e528336-c1a6-4657-96a6-5eb5121e757b

atenolol 50 mg / chlorthalidone 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1524270382TenoreticNDAAlmatica Pharma Inc.2015-04-21ATENOLOL, CHLORTHALIDONEORALTABLETNDA0187604c7b43e9-d6f1-45e6-5699-5f5f2d075449

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782063ANDAMylan Pharmaceuticals Inc.2013-03-28ATENOLOL, CHLORTHALIDONEORALTABLETANDA07420399ae0271-47d8-4321-96e0-55124811df1a
2005915782ANDAWatson Laboratories, Inc.1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLETANDA073665a6794dfa-adbb-491b-9d48-f89a44e866c5
3009046200ANDAMajor1993-04-29ATENOLOL, CHLORTHALIDONEORALTABLETANDA073582424a34e0-9100-4232-8de6-bc90c21e6b3f
4534890531ANDAMutual Pharmaceutical Company, Inc.1993-04-29ATENOLOL, CHLORTHALIDONEORALTABLETANDA073582b4cfa459-c1c3-4fe2-ac2d-afeea2b96cca

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950743ANDARebel Distributors Corp1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA073665cd4f6a14-a2eb-4157-83a7-91ab4e9926e5
2332610942ANDAAidarex Pharmaceuticals Llc1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA07366518a6026b-a790-44b6-bf03-a17a1a7dac7a
3433530149ANDAAphena Pharma Solutions - Tennessee, Llc1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA07366573705d59-49fa-4e5d-8e3b-13bc2ac8796b
4521250514ANDARemedyrepack Inc.2013-05-22ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA0736650186ea57-212f-42a1-85c3-1dd56cf96793
5521250532ANDARemedyrepack Inc.2013-05-23ATENOLOL, CHLORTHALIDONEORALTABLET003782063ANDA0742033658041f-d6a3-4199-932b-a27a98ce6ce7
6548682683ANDAPhysicians Total Care, Inc.1995-05-02ATENOLOL, CHLORTHALIDONEORALTABLET00591578201ANDA07366584e9de8f-27c3-4177-827a-6992495511ac
7552890993ANDAPd-Rx Pharmaceuticals, Inc.1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA07366578b374f8-0e16-4c15-85c1-16609ac3aca2
8636292909ANDABryant Ranch Prepack1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA073665b5de77fc-8b73-44eb-ab0f-27422a8d60b4
9687889042ANDAPreferred Pharmaceuticals, Inc.1992-08-01ATENOLOL, CHLORTHALIDONEORALTABLET005915782ANDA073665e5929809-f517-4383-a754-ba8afc00e5c4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072301ATENOLOL AND CHLORTHALIDONEALVOGEN IPCO SARL1990-05-31ANDA072301_001
2ANDA072302ATENOLOL AND CHLORTHALIDONEALVOGEN IPCO SARL1990-05-31ANDA072302_001
3ANDA073581ATENOLOL AND CHLORTHALIDONEMUTUAL PHARMACEUTICAL CO INC1993-04-29ANDA073581_001
4ANDA073582ATENOLOL AND CHLORTHALIDONEMUTUAL PHARMACEUTICAL CO INC1993-04-29ANDA073582_001
5ANDA073665ATENOLOL AND CHLORTHALIDONEWATSON LABORATORIES INC1992-07-02ANDA073665_001, ANDA073665_002
6ANDA074107ATENOLOL AND CHLORTHALIDONETruePLIVA INC1997-09-24ANDA074107_001, ANDA074107_002
7ANDA074203ATENOLOL AND CHLORTHALIDONEMYLAN PHARMACEUTICALS INC1993-10-31ANDA074203_001, ANDA074203_002
8ANDA074404ATENOLOL AND CHLORTHALIDONETrueNOSTRUM LABORATORIES INC1998-05-14ANDA074404_001, ANDA074404_002
9NDA018760TENORETIC 100ALVOGEN IPCO SARL1984-06-08NDA018760_001, NDA018760_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072301_001RXATENOLOL (50MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1990-05-31ATENOLOL AND CHLORTHALIDONE
2ANDA072302_001RXATENOLOL (100MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1990-05-31ATENOLOL AND CHLORTHALIDONE
3ANDA073581_001RXCHLORTHALIDONE (25MG), ATENOLOL (50MG)ORALTABLETFalseAB1993-04-29ATENOLOL AND CHLORTHALIDONE
4ANDA073582_001RXATENOLOL (100MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1993-04-29ATENOLOL AND CHLORTHALIDONE
5ANDA073665_001RXATENOLOL (50MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1992-07-02ATENOLOL AND CHLORTHALIDONE
6ANDA073665_002RXCHLORTHALIDONE (25MG), ATENOLOL (100MG)ORALTABLETFalseAB1992-07-02ATENOLOL AND CHLORTHALIDONE
7ANDA074107_001discontinuedCHLORTHALIDONE (25MG), ATENOLOL (50MG)ORALTABLETFalse1997-09-24ATENOLOL AND CHLORTHALIDONE
8ANDA074107_002discontinuedCHLORTHALIDONE (25MG), ATENOLOL (100MG)ORALTABLETFalse1997-09-24ATENOLOL AND CHLORTHALIDONE
9ANDA074203_001RXATENOLOL (50MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1993-10-31ATENOLOL AND CHLORTHALIDONE
10ANDA074203_002RXATENOLOL (100MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1993-10-31ATENOLOL AND CHLORTHALIDONE
11ANDA074404_001discontinuedCHLORTHALIDONE (25MG), ATENOLOL (50MG)ORALTABLETFalse1998-05-14ATENOLOL AND CHLORTHALIDONE
12ANDA074404_002discontinuedATENOLOL (100MG), CHLORTHALIDONE (25MG)ORALTABLETFalse1998-05-14ATENOLOL AND CHLORTHALIDONE
13NDA018760_001RXCHLORTHALIDONE (25MG), ATENOLOL (100MG)ORALTABLETTrueAB1984-06-08TENORETIC 100
14NDA018760_002RXATENOLOL (50MG), CHLORTHALIDONE (25MG)ORALTABLETFalseAB1984-06-08TENORETIC 100

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10186ea57-212f-42a1-85c3-1dd56cf96793 (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: December 2012Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-221521250514
20ebcca1e-ca16-4483-429a-aec5dcacd1dc (view SPL)TENORETIC (atenolol and chlorthalidone) TabletsprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals LpMANUFACTURE2012-10-318003100117, 003100115
31203ed3a-7a1f-4598-818e-7c2e7a6d1ce7 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-08-201353560859
418a6026b-a790-44b6-bf03-a17a1a7dac7a (view SPL)Atenolol and ChlorthalidoneTablets USP Revised: December 2012 Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-221332610942
51c3c2cbf-e307-4327-a044-69451aef66ae (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636293738
61e528336-c1a6-4657-96a6-5eb5121e757b (view SPL)Atenolol and ChlorthalidoneprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2013-05-092687889041
73658041f-d6a3-4199-932b-a27a98ce6ce7 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-231521250532
8424a34e0-9100-4232-8de6-bc90c21e6b3f (view SPL)ATENOLOL AND CHLORTHALIDONE TABLETS USPprescriptionHuman PrescriptionMajor2011-09-012009046200
94c7b43e9-d6f1-45e6-5699-5f5f2d075449 (view SPL)TENORETIC (atenolol and chlorthalidone) TabletsprescriptionHuman PrescriptionAlmatica Pharma Inc.manufacture, pack2012-10-3110524270382, 524270383
1073705d59-49fa-4e5d-8e3b-13bc2ac8796b (view SPL)Atenolol and ChlorthalidoneTablets USP Revised: December 2012 Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-201433530149
1178b374f8-0e16-4c15-85c1-16609ac3aca2 (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-10-016552890993
1284e9de8f-27c3-4177-827a-6992495511ac (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-281548682683, 548683064
1399ae0271-47d8-4321-96e0-55124811df1a (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-02-263003782063, 003782064
14a6794dfa-adbb-491b-9d48-f89a44e866c5 (view SPL)Atenolol and ChlorthalidoneTablets USP Revised: December 2012 Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-01-259005915782, 005915783
15b4cfa459-c1c3-4fe2-ac2d-afeea2b96cca (view SPL)ATENOLOL AND CHLORTHALIDONE TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2012-11-134534890531, 534890532
16b5de77fc-8b73-44eb-ab0f-27422a8d60b4 (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636292909
17cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 (view SPL)Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-101216950743, 216950744
18e5929809-f517-4383-a754-ba8afc00e5c4 (view SPL)Atenolol and ChlorthalidoneprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2013-05-092687889042

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