FDA.reportPublic FDA data

hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet

RxCUI
485471
RxNorm name
hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet
Display name
hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet
Full name
hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e842fa14-b18e-4463-9bf1-a1c8700fe33c2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485471
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485471
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEHikma Pharmaceuticals USA Inc.17561aae-f0bc-4ffc-a007-985b17e9baf02025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485471
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited9492a1cd-c012-4b43-931d-235220065e1e2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485471

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
17561aae-f0bc-4ffc-a007-985b17e9baf0irbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet [SCD] · HCTZ 25 MG / irbesartan 300 MG Oral Tablet [SY]321These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199720251201
e842fa14-b18e-4463-9bf1-a1c8700fe33cirbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet [SCD] · HCTZ 25 MG / irbesartan 300 MG Oral Tablet [SY]318These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, for oral use Initial U.S. Approval: 199720260120
466dd0d2-9815-4c3e-b66b-d0732b3ba8e9irbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet [SCD] · HCTZ 25 MG / irbesartan 300 MG Oral Tablet [SY]314These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199720251219
9492a1cd-c012-4b43-931d-235220065e1eirbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet [SCD] · HCTZ 25 MG / irbesartan 300 MG Oral Tablet [SY]34These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, for oral use Initial U.S. Approval: 199720230130
c7750b68-b3d8-45fa-b134-bf75f6ac510eirbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · hydrochlorothiazide 25 MG / irbesartan 300 MG Oral Tablet [SCD] · HCTZ 25 MG / irbesartan 300 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 199720100119