FDA.reportPublic FDA data

HCTZ 12.5 MG / valsartan 80 MG Oral Tablet

RxCUI
200284
RxNorm name
HCTZ 12.5 MG / valsartan 80 MG Oral Tablet
Display name
HCTZ 12.5 MG / valsartan 80 MG Oral Tablet
Full name
HCTZ 12.5 MG / valsartan 80 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 2 · 21 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: 200284
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAvKARE05ba1369-6484-75d4-e063-6294a90a63e42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions09c55798-5313-4250-8d8f-9c5644e8c1b02026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCf8b0a8ab-4549-4553-a127-bf2c0291a4b12025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46addda8-f798-4207-b8fb-ea75c5903a362025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedc5bc7c55-b50c-4e61-ad1f-5ebb607c262f2024-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.973973a3-9fec-4afc-910f-187f099dfe2d2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1f2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.d74a85de-5917-401a-b92d-6a95da5d30a62023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAmneal Pharmaceuticals of New York LLCd5a1db33-3046-407c-a557-6b41642164a92023-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.3ba1f9f9-0037-4522-8605-e27dc8552b5b2023-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited3b80f726-9e1e-4d44-ad4f-afd10e26292f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
valsartan and hydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limitedbd199010-1d85-4011-939c-4704ecfaba1f2022-11-05Exact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited771afba6-8769-4ea8-afec-358dba0aaefe2022-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe0349fe8-90a4-4236-9686-f0c9c00a001c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPa06ee3c1-bd0d-4dda-a453-1655eebffdae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe1f94546-c71c-4175-9384-20238181e05f2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPbe008c6a-6036-4abf-a3fc-450465c88d552019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200284

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 26 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
167f49f0-2d39-49a2-9f9e-1359a7c7ba3dHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-65807aea9569HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-bf2c0291a4b1HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-9c5644e8c1b0HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-e27dc8552b5bHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-baa0-45b9-96f8-980d5a09a683HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-6a95da5d30a6HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-5c074844dba7HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-5ebb607c262fHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-187f099dfe2dHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1fHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]310These 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: 199820240130
771afba6-8769-4ea8-afec-358dba0aaefeHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
d5a1db33-3046-407c-a557-6b41642164a9HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-4704ecfaba1fHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]34VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS20221105
cb04fbc5-7d84-4e0d-9020-70b73024ed77HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
6f0c91e6-1ec9-4a93-9064-34b459ea0aacHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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-afd10e26292fHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
a06ee3c1-bd0d-4dda-a453-1655eebffdaeHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
e1f94546-c71c-4175-9384-20238181e05fHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
05ba1369-6484-75d4-e063-6294a90a63e4HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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
e0349fe8-90a4-4236-9686-f0c9c00a001cHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]32These 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: 199820220502
be008c6a-6036-4abf-a3fc-450465c88d55HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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, for oral use Initial U.S. Approval: 199820191001
9ea4336c-6450-419e-8185-0072c07bba76HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]32VALSARTAN AND HYDROCHLOROTHIAZIDE20151110
46addda8-f798-4207-b8fb-ea75c5903a36HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 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: 199820250529
7b7dd683-78d0-468e-b1c9-e5b212a19c9aHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]31These 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-a552-7a37017e0a7aHCTZ 12.5 MG / valsartan 80 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [SCD] · HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [SY]3120091228