Amiloride / Hydrochlorothiazide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2011-08-07)
Oldest Current Product
1989-12-01
License(s)
ANDA
RxNORM
ORAL TABLET\AMILORIDE:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\AMILORIDE HYDROCHLORIDE: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET\AMILORIDE HYDROCHLORIDE: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\AMILORIDE: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

amiloride hydrochloride 5 mg / hydrochlorothiazide 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780577ANDAMylan Pharmaceuticals Inc.1991-10-31AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDEORALTABLETANDA073209dc7aef5e-9585-45b9-b317-4af570202ef5
2005550483ANDABarr Laboratories Inc.1989-12-01AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDEORALTABLETANDA0711118b2c581a-f955-4a8e-bf85-e768e903fd10

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680667ANDAPhysicians Total Care, Inc.1996-05-16AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDEORALTABLET003780577ANDA07320971f5c703-94d4-49b0-9c2d-374b9cbcab85

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070347HYDRO-RIDETruePAR PHARMACEUTICAL INC1990-12-25ANDA070347_001
2ANDA070795AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC1988-04-17ANDA070795_001
3ANDA071111AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBARR LABORATORIES INC1988-05-10ANDA071111_001
4ANDA073209AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC1991-10-31ANDA073209_001
5ANDA073334AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1991-07-19ANDA073334_001
6ANDA073357AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1991-11-27ANDA073357_001
7NDA018201MODURETIC 5-50TrueMERCK RESEARCH LABORATORIES DIV MERCK CO INCNDA018201_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070347_001discontinuedAMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalse1990-12-25HYDRO-RIDE
2ANDA070795_001discontinuedHYDROCHLOROTHIAZIDE (50MG), AMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS)ORALTABLETFalse1988-04-17AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
3ANDA071111_001RXHYDROCHLOROTHIAZIDE (50MG), AMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS)ORALTABLETFalseAB1988-05-10AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
4ANDA073209_001RXAMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETTrueAB1991-10-31AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
5ANDA073334_001discontinuedAMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalse1991-07-19AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
6ANDA073357_001discontinuedHYDROCHLOROTHIAZIDE (50MG), AMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS)ORALTABLETFalse1991-11-27AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
7NDA018201_001discontinuedHYDROCHLOROTHIAZIDE (50MG), AMILORIDE HYDROCHLORIDE (EQ 5MG ANHYDROUS)ORALTABLETFalseMODURETIC 5-50

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
171f5c703-94d4-49b0-9c2d-374b9cbcab85 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-171548680667
28b2c581a-f955-4a8e-bf85-e768e903fd10 (view SPL)AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-12-134005550483
3dc7aef5e-9585-45b9-b317-4af570202ef5 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2011-08-074003780577

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