FDA.reportPublic FDA data

telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet

RxCUI
477130
RxNorm name
telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Display name
telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Full name
telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 9 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
rxcui: 477130
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.b88054b3-fafa-4b4e-acf5-5294e55557202026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA1e55800d-f77c-4950-a6d7-2055f4c7ea172026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
telmisartan and hydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELifestar Pharma LLC0c1bd0f4-034e-486c-ae46-2855c8c9ebda2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
TELMISARTAN AND HYDROCHLOROTHIAZIDETELMISARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare LLC47c8eee0-f0b7-4bd8-97e9-0029aa1b37db2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited681dfb5c-fc5c-427e-81f6-4b4e934978a22024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e80f232c-c1c4-4524-a0a5-d23ee0d1f3b72023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited5b476740-e3f0-4f68-b07c-cd9eb2fa27ca2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 477130

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b078dae2-664d-4144-847a-3b9d9b557402telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]326These highlights do not include all the information needed to use MICARDIS HCT safely and effectively. See full prescribing information for MICARDIS HCT. MICARDIS ® HCT (telmisartan and hydrochlorothiazide tablets), for oral use Initial U.S. Approval: 200020241231
b88054b3-fafa-4b4e-acf5-5294e5555720telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]315These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020260109
681dfb5c-fc5c-427e-81f6-4b4e934978a2telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]311These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020240620
e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]311These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020230915
47c8eee0-f0b7-4bd8-97e9-0029aa1b37dbtelmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]36These highlights do not include all the information needed to use TELMISARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN and HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020250630
1e55800d-f77c-4950-a6d7-2055f4c7ea17telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]35These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020260107
0c1bd0f4-034e-486c-ae46-2855c8c9ebdatelmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]34These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200020250820
5b476740-e3f0-4f68-b07c-cd9eb2fa27catelmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]33Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information20230123
1b303136-dccd-178b-e063-6394a90a35f8telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]32Telmisartan and Hydrochlorothiazide tablets, for oral use These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. Initial U.S. Approval: 200020260114
539cdfb4-b920-48fb-8176-fe23841e3d32telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [SCD] · HCTZ 25 MG / telmisartan 80 MG Oral Tablet [SY]32Micardis ® HCT (telmisartan and hydrochlorothiazide) Tablets, 40 mg/12.5 mg 80 mg/12.5 mg and 80 mg/25 mg20120214