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 6 of 135 · 2,685 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.868b1442-c412-4ee8-9798-f2408cd2249a2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC191d5710-7b8a-0b61-e063-6394a90afd412026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx4a2aad53-fcba-2a61-e063-6394a90a60162026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.408e797a-2cf3-4ee6-9f9b-179a8cf3d7992026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC03b11335-2e88-2f7b-e063-6394a90afe2a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacyeac57b4c-e79b-8d35-e053-2a95a90a9d252026-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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