FDA.reportPublic FDA data

amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet

RxCUI
848145
RxNorm name
amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Display name
amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Full name
amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet
Term type
PSN
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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exforge HCTAMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporation18d7820d-471f-4ee2-9ec6-25d8d27c77de2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.e9ecbadb-c548-6fe5-e053-2a95a90a75772025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited6fba5243-ee00-4825-a04a-321cb6b49c562024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848145

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
18d7820d-471f-4ee2-9ec6-25d8d27c77deamLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]433These highlights do not include all the information needed to use EXFORGE HCT safely and effectively. See full prescribing information for EXFORGE HCT. EXFORGE HCT ® (amlodipine, valsartan, and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 200920251212
5dbb43b1-3ea4-4fa5-a9aa-95d869ae65feamLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]411These highlights do not include all the information needed to use AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200920231214
6fba5243-ee00-4825-a04a-321cb6b49c56amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]48These highlights do not include all the information needed to use AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200920240517
9b76e441-e6a5-4036-8276-b7788ade5c44amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]46These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200920250410
e9ecbadb-c548-6fe5-e053-2a95a90a7577amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]43AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets. These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 200920250602
1ea4f227-b97a-49f1-bbc3-1dede2c1866damLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [SY] · amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [SY]41These highlights do not include all the information needed to use AMLODIPINE, VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for AMLODIPINE, VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use. Initial U.S. Approval: 200920250109