FDA.reportPublic FDA data

HCTZ 12.5 MG / valsartan 320 MG Oral Tablet

RxCUI
636042
RxNorm name
HCTZ 12.5 MG / valsartan 320 MG Oral Tablet
Display name
HCTZ 12.5 MG / valsartan 320 MG Oral Tablet
Full name
HCTZ 12.5 MG / valsartan 320 MG Oral Tablet
Term type
SY
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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackaf46984c-cb58-4886-baa2-0ee075242c272026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAvKARE05ba1369-6484-75d4-e063-6294a90a63e42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions09c55798-5313-4250-8d8f-9c5644e8c1b02026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCf8b0a8ab-4549-4553-a127-bf2c0291a4b12025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions93833cf2-631b-4058-809d-16cc11b858c02024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedc5bc7c55-b50c-4e61-ad1f-5ebb607c262f2024-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.973973a3-9fec-4afc-910f-187f099dfe2d2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.d74a85de-5917-401a-b92d-6a95da5d30a62023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAmneal Pharmaceuticals of New York LLCd5a1db33-3046-407c-a557-6b41642164a92023-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.3ba1f9f9-0037-4522-8605-e27dc8552b5b2023-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited3b80f726-9e1e-4d44-ad4f-afd10e26292f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
valsartan and hydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limitedbd199010-1d85-4011-939c-4704ecfaba1f2022-11-05Exact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited771afba6-8769-4ea8-afec-358dba0aaefe2022-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP411caa05-5eff-4285-a940-7f6d2429ba812019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPec24af8d-29a3-4217-8f06-ac217ea55b9e2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAmneal Pharmaceuticals LLCc9acbc95-3629-4276-842b-5c074844dba72019-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636042

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
167f49f0-2d39-49a2-9f9e-1359a7c7ba3dvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]31015These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS, safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820231211
d76a0419-05ee-437e-884c-65807aea9569valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]334These 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
f8b0a8ab-4549-4553-a127-bf2c0291a4b1valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]323These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820250731
09c55798-5313-4250-8d8f-9c5644e8c1b0valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]321These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820260113
3ba1f9f9-0037-4522-8605-e27dc8552b5bvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]320These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820230427
5ed6f8bd-baa0-45b9-96f8-980d5a09a683valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]315These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820210610
d74a85de-5917-401a-b92d-6a95da5d30a6valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]312These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820231130
c9acbc95-3629-4276-842b-5c074844dba7valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]312These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820190202
c5bc7c55-b50c-4e61-ad1f-5ebb607c262fvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]311These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820240615
973973a3-9fec-4afc-910f-187f099dfe2dvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]311These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820240610
771afba6-8769-4ea8-afec-358dba0aaefevalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]38These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820221102
ddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc8valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]36These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820240212
93833cf2-631b-4058-809d-16cc11b858c0valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]34These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820241108
d5a1db33-3046-407c-a557-6b41642164a9valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]34These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS . VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval:199820230508
bd199010-1d85-4011-939c-4704ecfaba1fvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]34VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS20221105
cb04fbc5-7d84-4e0d-9020-70b73024ed77valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]34These 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
f7b0fc9c-0b94-4625-841c-ace024d1285avalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]33These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820230818
9e17c46f-4e38-488a-9ff0-d7f0d43ae0e1valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]33These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820230607
3b80f726-9e1e-4d44-ad4f-afd10e26292fvalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]33These highlights do not include all the information needed to use valsartan and hydrochlorothiazide tablets safely and effectively. See full prescribing information for valsartan and hydrochlorothiazide tablets. VALSARTAN and HYDROCHLOROTHIAZIDE Tablets, USP for oral use. Initial U.S. Approval: 199820230127
411caa05-5eff-4285-a940-7f6d2429ba81valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]33These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets USP, for oral use Initial U.S. Approval: 199820191101
ec24af8d-29a3-4217-8f06-ac217ea55b9evalsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]33These highlights do not include all the information needed to use valsartan and hydrochlorothiazide tablets safely and effectively. See full prescribing information for valsartan and hydrochlorothiazide tablets. VALSARTAN and HYDROCHLOROTHIAZIDE Tablets, USP for oral use. Initial U.S. Approval: 199820191001
05ba1369-6484-75d4-e063-6294a90a63e4valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]32VALSARTAN and HYDROCHLORTHIAZIDE tablets, for oral use These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. Initial U.S. Approval:199820260119
1bace05a-ac18-4bf4-97b3-641ad1e6fd78valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]32These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 199820150507
af46984c-cb58-4886-baa2-0ee075242c27valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [SY]31These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 199820260206