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 8 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e842fa14-b18e-4463-9bf1-a1c8700fe33c2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.686a5743-adc9-4729-9dbf-5cbc2c23897a2026-01-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEAvKARE017bc6a3-5b3d-2381-e063-6394a90abece2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDECoupler LLC44fd38d2-cb8b-d0e8-e063-6294a90a994e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAvKARE05ba1369-6484-75d4-e063-6294a90a63e42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANAvKARE71902893-55da-4286-8b25-b528641489ef2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutionsc2396dd4-faf2-447c-bda5-2362dbbbe3522026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions22036b58-c1fe-45b5-ae08-93fdaf7165282026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANSolco Healthcare US, LLC77442f0b-b522-4b19-ac1f-f0ce8576f0be2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions90bb2207-2eaf-495b-a222-c69d4db9e7a32026-01-14Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.6c4cd90b-44c0-4da5-8f26-f0fa465acce42026-01-13Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions09c55798-5313-4250-8d8f-9c5644e8c1b02026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.b88054b3-fafa-4b4e-acf5-5294e55557202026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEAvPAKef56450d-86d3-2654-e053-2995a90a142c2026-01-08Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAdvagen Pharma Ltda5525a2a-d2c7-411b-9ffc-0cc4fe77f7c72026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.8808879d-8c7e-45d1-8a49-c05d2cf845d32026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.00f67e1a-6999-4295-9c9f-fcb1ce9711b82026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.ec23c75d-68d5-46d0-be56-b96ddba19ed62026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA1e55800d-f77c-4950-a6d7-2055f4c7ea172026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: U5SYW473RQ
Olmesartan medoxomil, amlodipine and hydrochlorothiazideOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.45e975ff-07b1-411a-96ee-a011d1619b1e2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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