FDA.reportPublic FDA data

NDC 59368-383-01 - 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
59368-383
Requested NDC
59368-383-01
Package NDCs from labels
59368-383-01
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 1 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANREMEDYREPACK INC.57da6ef2-2e86-4e4d-90df-73a2a8cf97f62026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANREMEDYREPACK INC.91215664-6e19-4e04-9ae7-ab56647994262026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANRedpharm Drug5743c58e-deab-ac93-e063-6294a90ac1eb2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
WIDAPLIKTELMISARTAN, AMLODIPINE AND INDAPAMIDEAzurity Pharmaceuticals, Inc.a30ff81d-420b-40ea-83d8-670260a93fff2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANREMEDYREPACK INC.09d31eee-cd22-4918-a889-3eb4d29695252026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAlembic Pharmaceuticals Limited4be6575f-ea8d-4cd8-a49d-3d1c93f2621a2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAlembic Pharmaceuticals Inc.c62d424c-7630-413c-be2c-3932831c3f1d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepack830741dd-3f3c-4f8e-88c6-dc112166f4772026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepacka5ded796-3555-4476-8b37-0cdc88d7594a2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackc55e4fe1-f04d-4995-a706-9f432fde57e42026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANGlenmark Pharmaceuticals Inc., USAc6eb489d-2946-4c14-839f-d4af761ead312026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANMacleods Pharmaceuticals Limited671d5a85-4146-43b4-9d7d-ca53268eb2a62026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAvKARE71902893-55da-4286-8b25-b528641489ef2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANSolco Healthcare US, LLC77442f0b-b522-4b19-ac1f-f0ce8576f0be2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.b88054b3-fafa-4b4e-acf5-5294e55557202026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA1e55800d-f77c-4950-a6d7-2055f4c7ea172026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANA-S Medication Solutionseaed12cd-5bfe-4c98-9afc-025ed86a294f2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TELMISARTANTELMISARTANChartwell RX, LLC.beaaf383-730f-4411-b5e7-15c32b53a3382025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANNorthStar RxLLC9c22a318-d1f2-4788-9331-66fed71ebf382025-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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