FDA.reportPublic FDA data

irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet

RxCUI
310792
RxNorm name
irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
Display name
irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
Full name
irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5eabb13d-f6fd-4091-9909-c4f0c59222892026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack85494404-484c-45a1-8487-f9eb2a76490d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke6c35575-9c3f-42f8-b8b8-577a29f9d3812026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5029c9f7-6233-4a6f-ace9-2268cc8e286d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53ce6e4f-db3a-4789-8bef-1e459fa78b792026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.83f4acc1-697a-4770-b554-1b9a8fb5de742026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e842fa14-b18e-4463-9bf1-a1c8700fe33c2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.181324c5-256f-4570-a0bb-8bc908deb2e22025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEHikma Pharmaceuticals USA Inc.17561aae-f0bc-4ffc-a007-985b17e9baf02025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46d77ed8-ece2-4f51-b1a4-4a440e2dce2d2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
AvalideIRBESARTAN AND HYDROCHLOROTHIAZIDESanofi-Aventis U.S. LLC0d91895e-c869-4b33-9b83-d55c1ad6317e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1898f438-4571-4aab-ae06-9bf1aabf04862025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc7ce5a69-1e07-4d52-b815-ce64ac3731ac2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited9492a1cd-c012-4b43-931d-235220065e1e2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP97b09783-7bba-4f7a-b1b3-86ccf12c7ecc2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc5f26357-40f3-49f4-99f2-845a8dda5f392019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310792

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 24 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e6c35575-9c3f-42f8-b8b8-577a29f9d381irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]3104These 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: 199720260514
85494404-484c-45a1-8487-f9eb2a76490dirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]3103These 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: 199720260529
53ce6e4f-db3a-4789-8bef-1e459fa78b79irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]3102These 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: 199720260318
5029c9f7-6233-4a6f-ace9-2268cc8e286dirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]3101These 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: 199720260407
0d91895e-c869-4b33-9b83-d55c1ad6317eirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]324These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 199720251007
17561aae-f0bc-4ffc-a007-985b17e9baf0irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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
83f4acc1-697a-4770-b554-1b9a8fb5de74irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]316These 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: 199720260128
1898f438-4571-4aab-ae06-9bf1aabf0486irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]315These 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: 199720250902
466dd0d2-9815-4c3e-b66b-d0732b3ba8e9irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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
181324c5-256f-4570-a0bb-8bc908deb2e2irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]312These 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: 199720251218
72fa8cd4-bc2a-4a7d-8feb-2d60e077d801irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]311These 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: 199720251231
e6d11cd6-7204-4031-a6c5-8f6a33568ab4irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]38These 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 useInitial U.S. Approval: 199720250127
46d77ed8-ece2-4f51-b1a4-4a440e2dce2dirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]37These 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: 199720251110
c7ce5a69-1e07-4d52-b815-ce64ac3731acirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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, USP, for oral use Initial U.S. Approval: 199720241001
5eabb13d-f6fd-4091-9909-c4f0c5922289irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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: 199720231115
9492a1cd-c012-4b43-931d-235220065e1eirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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
2f29f67a-2918-4318-9cb1-5e0eb22b35a3irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]34These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 199720121005
89701339-861a-4e54-a3d6-cf84046e54f2irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]33These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 199720240520
97b09783-7bba-4f7a-b1b3-86ccf12c7eccirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]33These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 199720210101
c5f26357-40f3-49f4-99f2-845a8dda5f39irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]33These 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: 199720191101
f5b37c13-e10c-4623-aac5-9a6512b2f701irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]32These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 199720150507
c7750b68-b3d8-45fa-b134-bf75f6ac510eirbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 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
89b8360b-2e30-4ad1-b7b6-df0866f58a22irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [SCD] · HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [SY]31These 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: 199720221227