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 28 of 29 · 575 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP6dd115b5-9268-4b66-bae8-0aa2605ebbd32021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP198d5151-7982-4639-9fe1-6573a45293482021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP7897d182-2859-4a40-af4d-aaa9d9720fd92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCe8ca7334-4b58-4f4b-bf36-0ab47b60ff7c2020-12-14Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC191b9e48-7d44-4378-9f3f-b4a999080c8c2020-11-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDECIPLA USA INC.4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2020-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCec70ea28-a219-45d1-9d5b-6a79c7ef49872020-10-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.841b7962-bf5d-4c45-b594-80b17ba5187d2020-09-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VasereticENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEBausch Health US, LLCbf3007e2-8fcc-48de-8fd5-55e95033d62f2020-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.f3c4f7ed-e667-4528-a675-b032c2a4425d2020-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
telmisartanTELMISARTANProficient Rx LP593a53a4-91bc-4e4a-aeff-08fc2efe3dd42020-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, Inc.02e96a51-1d56-460c-8c20-3d6f37e0ce462020-05-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.ab5e9ae4-e575-4a63-99f3-2bde36bdd5082020-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSAphena Pharma Solutions - Tennessee, LLCe2903227-4a79-4a9c-b96b-073b8e41fb012020-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP33710c3c-6f17-457a-8665-04c23bca8b752019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPa06ee3c1-bd0d-4dda-a453-1655eebffdae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP411caa05-5eff-4285-a940-7f6d2429ba812019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe1f94546-c71c-4175-9384-20238181e05f2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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