FDA.reportPublic FDA data

HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet

RxCUI
979464
RxNorm name
HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet
Display name
HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet
Full name
HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.fd07d24c-6db1-4f6b-b226-68abba3a33212026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.ee1eaaf6-050b-48af-942b-5e3451edc1642026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.cdf59426-2a2f-4a60-943a-e6cef3eb31e12026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.6eab1c0a-9328-42a6-8eae-d4e105c547162026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack1d6712a3-bfb3-4081-b8f6-6057eb4baa272026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd838e918-2463-79f6-e053-2a95a90a948d2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsdc9512cf-db66-40e9-afcb-1d6a722772e82026-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.deafd195-7a1b-4ad8-a371-2cd9f433dea52025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.acecced9-2a61-435d-b7d4-b151cb7b7e5d2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEJubilant Cadista Pharmaceuticals Inc.e0b74a86-3d36-1af0-e538-41b45b8d2cc32025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf5f462c6-0604-49d3-af8f-fecbde23be992025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
HYZAARLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEOrganon LLC4116ccde-2e23-45f4-b12f-6337df8777442025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC6d677f9e-c0e4-4d6e-bea2-a58e986e46352025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack68a99bb3-69ad-42e2-9d50-390f757446712025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limitedbbf7e20d-dfc2-4115-8788-c0cac15a11482025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENorthStar Rx LLC25318baf-9c2f-458f-b9ea-f52dabca49af2025-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f42025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAvKAREe78b2195-a2da-3d03-e053-2a95a90a7d562025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf9cfb39e-4367-40a0-86ee-138645aace562025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limiteddc177d6c-c754-4379-8c2f-1cf6f52f950a2025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 979464

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 42 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e0f63126-6890-48bf-9c25-444dc5974ecdlosartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet [SCD] · HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet [SY] · HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet [SY] · HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet [SY]51These highlights do not include all the information needed to use LOSARTAN POSTASSIUM AND HYDROCHLOROTHIAZIDE​TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use. Initial U.S. Approval: 199520250205
c6ed6f74-0eca-4f99-8c7e-dd3f56167f01losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet [PSN] · hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet [SCD] · HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet [SY] · HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet [SY] · HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet [SY]51These highlights do not include all the information needed to use LOSARTAN POSTASSIUM AND HYDROCHLOROTHIAZIDE​TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use. Initial U.S. Approval: 199520240501