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 17 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd8284747-07b6-9775-e053-2a95a90ad52d2025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd88ad738-a915-7679-e053-2a95a90a58c72025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.93f6a018-8b3d-4f40-be25-902daec19aea2025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDIRECT RXcbe5e01e-67ca-f8a2-e053-2995a90a0d152025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxcf4278a3-fbb7-a8ab-e053-2a95a90abc0f2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ed9593-a587-55bb-e053-2995a90a8a9a2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ee193e-bf78-3134-e053-2a95a90a65d22025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd2021060-94d7-3e1d-e053-2995a90a10ee2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_Rx8de04bf2-83dd-c494-e053-2a95a90abade2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAmerican Health Packagingba764ce4-36fe-4aa4-96a4-d0479b875b4f2025-01-08Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAdvanced Rx Pharmacy of Tennessee, LLCecac0280-6faa-e7f3-e053-2995a90a2bd92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: U5SYW473RQ
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4a2c2b8f-1479-4555-9ba8-ca44070032962024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANBryant Ranch Prepacke2deff49-b75e-4aaa-8114-d5ea1e3a94a52024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackb4ae8694-2af4-4acb-8634-b40c1cb6fb412024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackf13e0919-5ee2-4855-b7c8-c8ab423769dd2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQuality Care Products, LLCa6241e63-1952-4dfa-ba94-c406059501dd2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEQuality Care Products LLCa2de8e26-ef5a-41c7-888b-990629b111452024-12-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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