FDA.reportPublic FDA data

NDC 16729-321-46 - olmesartan medoxomil

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
16729-321
Requested NDC
16729-321-46
Package NDCs from labels
16729-321-10, 16729-321-15, 16729-321-16, 16729-321-17, 16729-321-45, 16729-321-46
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
olmesartan medoxomil - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-29HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - REMEDYREPACK INC.REMEDYREPACK INC.2025-03-10HUMAN PRESCRIPTION DRUG LABEL
OLMESARTAN MEDOXOMIL - direct rxdirect rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - Bryant Ranch PrepackBryant Ranch Prepack2024-08-27HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - A-S Medication SolutionsA-S Medication Solutions2023-11-07HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - A-S Medication SolutionsA-S Medication Solutions2023-08-28HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - REMEDYREPACK INC.REMEDYREPACK INC.2019-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-321-10olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
16729-321-15olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-321-16olmesartan medoxomil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009
16729-321-17olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
16729-321-45olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
16729-321-46olmesartan medoxomil100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-321OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy NDC, 6 package rows20240718_e5dbca00-4e1b-4479-b829-021b11bc021e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-321-10EA - Each16729-321d1b3d3ec-be0d-4bdd-8ae2-484645b8f76612017-05-03
16729-321-15EA - Each16729-321e0daec77-c6b6-40ce-b831-b404d11ea4c812017-05-03
16729-321-17EA - Each16729-321a1cb3908-cd4c-4a7f-83dd-f217a6ddd4f012017-05-03

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 63 of 106 · 2,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited744c1785-42b2-46a5-b0f4-2887a9ec20512025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine and olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAscend Laboratories, LLCc1204fbe-d086-43cf-bbaa-efec9cd0487c2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.53b8d406-a4f3-46ee-9aec-d70f7d8068762025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349373
rxcui: 349401
rxcui: 349405
unii: 6M97XTV3HD
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c7472025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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