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 21 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited6fba5243-ee00-4825-a04a-321cb6b49c562024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack36fbc5fc-4a75-4aa3-bed1-78944135ae112024-05-17Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.1884db5f-72b5-6b0c-e063-6394a90a0e492024-05-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions1bb08103-04ee-47a6-a9ad-290e169feb512024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsc8740506-c679-4c41-a96a-8ddbcddd72c62024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.abf2fe45-8b69-4d3c-981e-289c0aa3e98b2024-05-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPc6ed6f74-0eca-4f99-8c7e-dd3f56167f012024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited35019655-9a30-4305-a262-936ad0e730712024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma Limited50a58159-9572-4445-9859-b392632597da2024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions98a58b54-bcf2-4726-800a-facf48d9155f2024-04-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.cba87d5b-9302-7b2c-e053-2a95a90a7f9d2024-04-17Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4c0b028d-f0f4-417f-a068-dca24e56113f2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepacka6ebafdc-4301-4d6c-b578-b3212648b13a2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ca13106-f68b-4894-aca2-03e74fff350c2024-04-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratoriesb8a55c23-b509-4790-88fa-9dc9bacd4bbe2024-03-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions2e4eee3a-fe0c-44aa-8ff1-b14b07a0c5bc2024-03-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPff448eb4-b48f-46f5-ac30-f03aad08f9f52024-03-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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