FDA.reportPublic FDA data

NDC 50090-3701-01 - Olmesartan Medoxomil and Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-3701
Requested NDC
50090-3701-01
Package NDCs from labels
50090-3701-1, 50090-3701-0, 50090-3701-01
Manufacturer
A-S Medication Solutions
Effective date
2024-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olmesartan Medoxomil and Hydrochlorothiazide - A-S Medication SolutionsA-S Medication Solutions2024-07-30Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3701-02023-02-07These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
50090-3701-12023-02-07These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
50090-3701-02023-01-30These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
50090-3701-12023-01-30These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3701-0Olmesartan Medoxomil and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3010
50090-3701-1Olmesartan Medoxomil and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3701OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240731_b78ad43f-f132-4f03-8c85-2cf9b3ab555b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3701-0EA - Each50090-370137cfdd86-074b-4750-bfca-aad79dc8bd8012024-09-09
50090-3701-1EA - Each50090-3701af4de883-b1ef-4241-9d04-a366f898155512024-09-09

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 3 of 135 · 2,685 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc57505d73-f2a8-430b-8703-a0a6bb733c7d2026-07-31Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.9f9cd7a7-be95-4ea8-8247-eb7ecbd369362026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack6b8585a2-22e0-4a4f-a1c3-24bcdec018342026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.0789baef-3424-43ab-a3fb-4908172da5652026-07-24Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm Drug57436cfa-9b94-89bf-e063-6394a90aa2642026-07-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.574d2679-c036-fa12-e063-6394a90aef332026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403855
rxcui: 403853
rxcui: 403854
unii: 0J48LPH2TH
unii: 6M97XTV3HD
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedd7214539-6c3d-466a-a474-6fde096fa1822026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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