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 29 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc5f26357-40f3-49f4-99f2-845a8dda5f392019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP1f6ab5e0-8320-4489-bed2-8c90c534e5ae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPbe008c6a-6036-4abf-a3fc-450465c88d552019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPec24af8d-29a3-4217-8f06-ac217ea55b9e2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP6c363351-6596-42bf-83c9-041bf231b7782019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC5eea66bd-589a-45f8-ba2c-dea66a939d592019-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEZydus Pharmaceuticals (USA) Inc.ee11db7b-91bd-4231-8783-889d98e4fa322019-02-23Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAmneal Pharmaceuticals LLCc9acbc95-3629-4276-842b-5c074844dba72019-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEExelan Pharmaceuticals Inc.b5a1b38c-0433-4649-a8b0-f72db0a96c452018-12-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
GUNA-DIURAMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITUITARY GLAND -Guna spa3f91cd92-eb6d-4bda-9cad-2e11e0b0fbe22018-12-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC61487122-8a94-4ad5-a307-7893e0b7510c2017-10-13Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC2febae4f-836e-4935-bd06-3495f87b3b822017-08-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril maleate and hydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDr. Reddy's Laboratories Limiteded4a55a6-cd6a-c74a-cb93-4b45641691a02010-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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