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 2 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.9f9cd7a7-be95-4ea8-8247-eb7ecbd369362026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANREMEDYREPACK INC.91215664-6e19-4e04-9ae7-ab56647994262026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.0789baef-3424-43ab-a3fb-4908172da5652026-07-24Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm Drug57436cfa-9b94-89bf-e063-6394a90aa2642026-07-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANRedpharm Drug5743c58e-deab-ac93-e063-6294a90ac1eb2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.574d2679-c036-fa12-e063-6394a90aef332026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedd7214539-6c3d-466a-a474-6fde096fa1822026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEBryant Ranch Prepack03b7e52e-0003-47c3-af12-93ef00800b372026-07-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.ee1eaaf6-050b-48af-942b-5e3451edc1642026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDESandoz Incf824b6ba-bd1c-41a8-8f6f-ad507b48f3e02026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEAvKARE569596a2-98f0-116a-e063-6294a90a3fa12026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril Maleate and HydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDESun Pharmaceutical Industries, Inc.7cb92cf2-46f2-4379-937c-168d230e43a42026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.cb7b7315-0170-492c-803f-60a6e75e55da2026-07-08Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.f083c321-3170-4982-b5cd-d3fdff7548572026-07-08Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.88aaa2a1-13be-4f56-ace6-66e8990280072026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.a85f69f5-ba97-478d-e053-2a95a90a0a972026-07-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
WIDAPLIKTELMISARTAN, AMLODIPINE AND INDAPAMIDEAzurity Pharmaceuticals, Inc.a30ff81d-420b-40ea-83d8-670260a93fff2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP4bc374e2-8650-41bc-8ce6-92062661bf8a2026-07-01Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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