FDA.reportPublic FDA data

NDC 71335-2425-01 - 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
71335-2425
Requested NDC
71335-2425-01
Package NDCs from labels
71335-2425-1, 71335-2425-2, 71335-2425-3, 71335-2425-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE - Bryant Ranch PrepackBryant Ranch Prepack2026-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2425-1OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET902
71335-2425-2OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET302
71335-2425-3OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2425OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 3 package rows20240702_78eb9041-a738-4056-8705-8c1dd13a4da4.zip

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 124 of 158 · 3,157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAurobindo Pharma Limitedb13a8b46-104e-4b75-8f4a-928d2204eff52024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4c0b028d-f0f4-417f-a068-dca24e56113f2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207804
rxcui: 403854
unii: 0J48LPH2TH
unii: 6M97XTV3HD
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepacka6ebafdc-4301-4d6c-b578-b3212648b13a2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
unii: 6M97XTV3HD
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ca13106-f68b-4894-aca2-03e74fff350c2024-04-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VAXR HCTHUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODEDeseret Biologicals, Inc.fdf8d21a-2ae1-4842-abf3-7378419959392024-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratoriesb8a55c23-b509-4790-88fa-9dc9bacd4bbe2024-03-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions2e4eee3a-fe0c-44aa-8ff1-b14b07a0c5bc2024-03-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAmneal Pharmaceuticals NY LLC02f9b562-6f7f-4783-bb0d-67c318073e1c2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.95406534-526e-4bca-b73d-1030623549a32024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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