FDA.reportPublic FDA data

HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]

RxCUI
809014
RxNorm name
HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]
Display name
HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]
Full name
HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 809014

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
d76a0419-05ee-437e-884c-65807aea9569hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBD34These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT ® (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 199820260213
d76a0419-05ee-437e-884c-65807aea9569Diovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSY34These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT ® (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 199820260213
d76a0419-05ee-437e-884c-65807aea9569HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SY34These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT ® (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 199820260213
d76a0419-05ee-437e-884c-65807aea9569Diovan HCT 80/12.5 Oral TabletSY34These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT ® (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 199820260213
d76a0419-05ee-437e-884c-65807aea9569Diovan HCT 80 MG / 12.5 MG Oral TabletPSN34These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT. DIOVAN HCT ® (valsartan and hydrochlorothiazide USP) tablets, for oral use Initial U.S. Approval: 199820260213
cb04fbc5-7d84-4e0d-9020-70b73024ed77HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SY4These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval : 199820120109
cb04fbc5-7d84-4e0d-9020-70b73024ed77Diovan HCT 80/12.5 Oral TabletSY4These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval : 199820120109
cb04fbc5-7d84-4e0d-9020-70b73024ed77hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBD4These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval : 199820120109
cb04fbc5-7d84-4e0d-9020-70b73024ed77Diovan HCT 80 MG / 12.5 MG Oral TabletPSN4These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval : 199820120109
cb04fbc5-7d84-4e0d-9020-70b73024ed77Diovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSY4These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval : 199820120109
7b7dd683-78d0-468e-b1c9-e5b212a19c9aDiovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSY1These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 199820121010
7b7dd683-78d0-468e-b1c9-e5b212a19c9ahydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBD1These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 199820121010
7b7dd683-78d0-468e-b1c9-e5b212a19c9aHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SY1These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 199820121010
7b7dd683-78d0-468e-b1c9-e5b212a19c9aDiovan HCT 80 MG / 12.5 MG Oral TabletPSN1These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 199820121010
7b7dd683-78d0-468e-b1c9-e5b212a19c9aDiovan HCT 80/12.5 Oral TabletSY1These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 199820121010
f6a79b4e-d7b3-4849-a552-7a37017e0a7aDiovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSY120091228
f6a79b4e-d7b3-4849-a552-7a37017e0a7aDiovan HCT 80 MG / 12.5 MG Oral TabletPSN120091228
f6a79b4e-d7b3-4849-a552-7a37017e0a7aHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SY120091228
f6a79b4e-d7b3-4849-a552-7a37017e0a7ahydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBD120091228
f6a79b4e-d7b3-4849-a552-7a37017e0a7aDiovan HCT 80/12.5 Oral TabletSY120091228