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 24 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions89ce2fb1-330c-45f9-bd37-b402feea93782023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions27b8f965-d73f-411c-aae6-bcae6e2811132023-10-23Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labsd6b933c6-f5f8-406a-84d6-b22c6040482a2023-10-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP9dd2f58b-d143-4d0c-a298-6d9390e6187a2023-10-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANAmneal Pharmaceuticals LLC20a60231-64f0-4751-aa81-6c0e643341792023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANModavar Pharmaceuticals LLCa075633a-2a2a-4e88-8ede-b49a3920a16c2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA51b0aed8-a229-4d2c-8fdf-aa957fddc41b2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANA-S Medication Solutions509cd338-24db-41d1-a115-9dc9991707172023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e80f232c-c1c4-4524-a0a5-d23ee0d1f3b72023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsb9e1bed7-fef9-434a-92f9-b70941176e3e2023-09-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited1af80800-e7a5-42e5-aa6c-3f61aff4a77b2023-08-31Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Pharmaceuticals (USA) Inc.fa69eeb8-ec82-4be1-8cb7-f64094ed957c2023-08-26Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions1bb00980-eeea-4722-b010-e208f3ec22142023-08-24Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANCadila Pharmaceuticals Limited353fcb30-2fa7-4ff1-8a18-26f3ec279d002023-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP8d992a4c-8740-4636-928f-bb808eae33362023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANAmneal Pharmaceuticals of New York LLCbf2dca37-ce9c-40e4-8ad6-b8186aa7fed12023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Benicar HCTOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.881a1c32-c209-4038-9c5e-c5e46c6e05462023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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