Captopril / Hydrochlorothiazide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2006-03-15)
Oldest Current Product
1997-12-29
License(s)
ANDA
RxNORM
ORAL TABLET\CAPTOPRIL:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\CAPTOPRIL: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET\CAPTOPRIL: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\CAPTOPRIL: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

captopril 25 mg / hydrochlorothiazide 15 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780081ANDAMylan Pharmaceuticals Inc.1997-12-29CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLETANDA074896d826812e-ede7-49e7-8384-29ec5b142ef3

captopril 25 mg / hydrochlorothiazide 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780083ANDAMylan Pharmaceuticals Inc.1997-12-29CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLETANDA074896d826812e-ede7-49e7-8384-29ec5b142ef3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685787ANDAPhysicians Total Care, Inc.2007-07-12CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLET003780083ANDA074896f0266d1a-2af2-415b-9433-69b5a690f9bb

captopril 50 mg / hydrochlorothiazide 15 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780084ANDAMylan Pharmaceuticals Inc.1997-12-29CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLETANDA074896d826812e-ede7-49e7-8384-29ec5b142ef3

captopril 50 mg / hydrochlorothiazide 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780086ANDAMylan Pharmaceuticals Inc.1997-12-29CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLETANDA074896d826812e-ede7-49e7-8384-29ec5b142ef3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684062ANDAPhysicians Total Care, Inc.2003-10-07CAPTOPRIL, HYDROCHLOROTHIAZIDEORALTABLET003780086ANDA074896f0266d1a-2af2-415b-9433-69b5a690f9bb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074788CAPTOPRIL AND HYDROCHLOROTHIAZIDETrueVINTAGE PHARMACEUTICALS LLC1997-12-29ANDA074788_001, ANDA074788_002, ANDA074788_003, ANDA074788_004
2ANDA074827CAPTOPRIL AND HYDROCHLOROTHIAZIDEG AND W LABORATORIES INC1997-12-29ANDA074827_001, ANDA074827_002, ANDA074827_003, ANDA074827_004
3ANDA074832CAPTOPRIL AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1997-12-29ANDA074832_001
4ANDA074896CAPTOPRIL AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC1997-12-29ANDA074896_001, ANDA074896_002, ANDA074896_003, ANDA074896_004
5ANDA075055CAPTOPRIL AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1998-06-18ANDA075055_001, ANDA075055_002, ANDA075055_003, ANDA075055_004
6NDA018709CAPOZIDE 25/15TrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1984-10-12NDA018709_001, NDA018709_002, NDA018709_003, NDA018709_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074788_001discontinuedCAPTOPRIL (25MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
2ANDA074788_002discontinuedHYDROCHLOROTHIAZIDE (25MG), CAPTOPRIL (25MG)ORALTABLETFalse1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
3ANDA074788_003discontinuedCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
4ANDA074788_004discontinuedCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
5ANDA074827_001RXHYDROCHLOROTHIAZIDE (15MG), CAPTOPRIL (25MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
6ANDA074827_002RXCAPTOPRIL (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
7ANDA074827_003RXCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
8ANDA074827_004RXHYDROCHLOROTHIAZIDE (15MG), CAPTOPRIL (50MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
9ANDA074832_001discontinuedCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
10ANDA074896_001RXCAPTOPRIL (25MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
11ANDA074896_002RXHYDROCHLOROTHIAZIDE (25MG), CAPTOPRIL (25MG)ORALTABLETTrueAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
12ANDA074896_003RXHYDROCHLOROTHIAZIDE (25MG), CAPTOPRIL (50MG)ORALTABLETFalseAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
13ANDA074896_004RXHYDROCHLOROTHIAZIDE (15MG), CAPTOPRIL (50MG)ORALTABLETTrueAB1997-12-29CAPTOPRIL AND HYDROCHLOROTHIAZIDE
14ANDA075055_001discontinuedCAPTOPRIL (25MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1998-06-18CAPTOPRIL AND HYDROCHLOROTHIAZIDE
15ANDA075055_002discontinuedHYDROCHLOROTHIAZIDE (25MG), CAPTOPRIL (25MG)ORALTABLETFalse1998-06-18CAPTOPRIL AND HYDROCHLOROTHIAZIDE
16ANDA075055_003discontinuedCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1998-06-18CAPTOPRIL AND HYDROCHLOROTHIAZIDE
17ANDA075055_004discontinuedHYDROCHLOROTHIAZIDE (15MG), CAPTOPRIL (50MG)ORALTABLETFalse1998-06-18CAPTOPRIL AND HYDROCHLOROTHIAZIDE
18NDA018709_001discontinuedHYDROCHLOROTHIAZIDE (15MG), CAPTOPRIL (25MG)ORALTABLETFalse1984-10-12CAPOZIDE 25/15
19NDA018709_002discontinuedCAPTOPRIL (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1984-10-12CAPOZIDE 25/15
20NDA018709_003discontinuedHYDROCHLOROTHIAZIDE (25MG), CAPTOPRIL (50MG)ORALTABLETFalse1984-10-12CAPOZIDE 25/15
21NDA018709_004discontinuedCAPTOPRIL (50MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1984-10-12CAPOZIDE 25/15

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1d826812e-ede7-49e7-8384-29ec5b142ef3 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2006-03-156003780081, 003780083, 003780084, 003780086
2f0266d1a-2af2-415b-9433-69b5a690f9bb (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-12-021548684062, 548685787

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