FDA.reportPublic FDA data

NDC 59368-385 - Micardis HCT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59368-385
Package NDCs from labels
59368-385-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Micardis HCT - Praxis, LLCPraxis, LLC2023-01-01HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 26 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP84dba61d-cae2-4f21-9a9e-3088f356f8382023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc4fe84e3-c291-4220-95c1-a2bd02b1e1342023-02-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited34703033-14c4-459c-8b8f-2f2e1145aff72023-01-30Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited9492a1cd-c012-4b43-931d-235220065e1e2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited3b80f726-9e1e-4d44-ad4f-afd10e26292f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited5b476740-e3f0-4f68-b07c-cd9eb2fa27ca2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: U5SYW473RQ
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited538ea34a-1ac3-48c8-b841-43be09285e122023-01-17Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC15e6f934-fe66-4640-bdf1-13b389cd9e542023-01-04Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
36d6f37a-1ffb-22c9-e063-6394a90ab5e136d6f15a-ed42-a8bf-e063-6294a90adcc02023-01-01Exact identifier
spl id: 36d6f37a-1ffb-22c9-e063-6394a90ab5e1
spl set id: 36d6f15a-ed42-a8bf-e063-6294a90adcc0
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP189ad040-07e9-42a5-854c-67633367da742023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Amiloride Hydrochloride and HydrochlorothiazideAMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.8b2c581a-f955-4a8e-bf85-e768e903fd102022-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa2022-11-07Exact identifier
unii: 0J48LPH2TH
valsartan and hydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limitedbd199010-1d85-4011-939c-4704ecfaba1f2022-11-05Exact identifier
unii: 0J48LPH2TH
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC35099fd1-1bc9-428b-9b9c-71f574cc41562022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited771afba6-8769-4ea8-afec-358dba0aaefe2022-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPa9098fc6-3d2a-404f-a4cd-2e181ebbd6262022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP98edae8a-99dc-4f26-a956-3ad58bf38a262022-06-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and hydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEProficient Rx LPaf0b3bef-be36-432a-884e-ea81e2d5c08e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.