FDA.reportPublic FDA data

amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]

RxCUI
848144
RxNorm name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]
Display name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]
Full name
amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]
Term type
SBD
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 · 1 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: 848144

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
18d7820d-471f-4ee2-9ec6-25d8d27c77deEXFORGE HCT 5 MG / 160 MG / 12.5 MG Oral Tablet [PSN] · amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT] [SBD] · Amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT] [SY] · Exforge HCT 5/160/12.5 (amlodipine / valsartan / HCTZ) Oral Tablet [SY] · Exforge HCT 5/160/12.5 Oral Tablet [SY]533These 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