FDA.reportPublic FDA data

NDC 59368-382 - Micardis

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
59368-382
Package NDCs from labels
59368-382-01
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 - 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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANPreferred Pharmaceuticals Inc.bf8e95fa-d181-4b46-8609-497e14a73dc12025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANNuCare Pharmaceuticals, Inc.3f021f06-99df-48d1-e063-6394a90a8d0f2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartan and hydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELifestar Pharma LLC0c1bd0f4-034e-486c-ae46-2855c8c9ebda2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TELMISARTAN AND HYDROCHLOROTHIAZIDETELMISARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare LLC47c8eee0-f0b7-4bd8-97e9-0029aa1b37db2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANPD-Rx Pharmaceuticals, Inc.56a72ddf-c2a2-45ce-91b1-1fcfbff52c102025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack32489e86-0432-4d74-92f6-15e7450f52fa2025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack44e810d4-cf04-41d3-bdf8-0681210a669f2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANAscend Laboratories, LLC29bddc43-2809-4e1f-ae35-2865e15e9bb62025-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepacke2deff49-b75e-4aaa-8114-d5ea1e3a94a52024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackb4ae8694-2af4-4acb-8634-b40c1cb6fb412024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackf13e0919-5ee2-4855-b7c8-c8ab423769dd2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANLifestar Pharma LLC3ff464e6-7a36-4544-a06f-7848414f77fc2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANZydus Lifesciences Limited2e3cc412-fa44-4304-aabc-d6e412f81fbf2024-08-12Exact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited681dfb5c-fc5c-427e-81f6-4b4e934978a22024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANNuCare Pharmaceuticals,Inc.a020e2a7-d1e7-8ae0-e053-2995a90abad32024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAurobindo Pharma Limitedfef6532d-438a-435e-a61f-216dd85513392024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANZydus Pharmaceuticals USA Inc.e61c209a-4fc3-4f5c-b526-6412f0b8897c2023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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